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Use of Sodium Stibogluconate as a Treatment for Leishmaniasis
This study has been completed.
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
First received: April 8, 2008
Last updated: May 2, 2017
Last verified: May 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Show Detailed Description
Leishmanias is a disease caused by the bite of sandflies and is found in many parts of the world including the Europe, Southwest Asia, Africa and the Middle East. This disease is a threat for military soldiers in areas where this disease is found. Sodium stibogluconate (SSG) or Pentostam (Glaxo Smith Kline, United Kingdom) is an Investigational New Drug (IND) product used by the Department of Defense for over 20 years to treat cutaneous, mucosal and visceral leishmanias. This drug is not licensed for commercial use in the United States because of very limited need for the product in the U.S.A. The primary objective of this protocol is to collect safety and efficacy data on the use of Pentostam for treatment of laboratory-confirmed leishmaniasis with SSG 20mg/kg/d IV for 10 days or 20 days and visceral and mucocutaneous leishmaniasis with SSG 20mg/kg/d IV for 28 days.
|Drug: Sodium Stibogluconate (SSG)
|Phase 1 Phase 2
|Study Type:
|Study Design:
|Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:
|Department of Defense Protocol for the Use of Sodium Stibogluconate (Pentostam) as a Treatment for Leishmaniasis
Resource links provided by NLM:
MedlinePlus related topics: LeishmaniasisU.S. FDA Resources
Further study details as provided by U.S. Army Medical Research and Materiel Command:
Primary Outcome Measures:
- Number of adverse events [ Time Frame: 5 years ]
|Actual Study Start Date:
|October 2004
|Study Completion Date:
|April 2016
|Primary Completion Date:
|April 2016 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: Treatment only
All consented subjects who meet all inclusion and no exclusion criteria will enter this open label protocol and be treated with Sodium Stibogluconate (SSG).
Drug: Sodium Stibogluconate (SSG)
100 mg/ml/vial. Treatment for laboratory-confirmed leishmaniasis with SSG 20mg/kg/d intravenously (IV) for 10 days or 20 days; visceral leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days as a second line of therapy for those failing or intolerant of Ambisome; and mucosal leishmaniasis will be treated with SSG 20mg/kg/d IV for 28 days.
Other Name: Pentostam (GlaxoSmithKline)
Show Detailed Description
|Ages Eligible for Study:
|Child, Adult, Senior
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- DoD healthcare beneficiary of any age and gender.
- Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection.
- Able to provide informed consent or assent (children).
- All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG.
Exclusion Criteria:
- Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period.
- History of hypersensitivity to pentavalent antimonials.
Any of the following on screening examination:
- QTc interval greater or equal to 0.5 sec
- Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias)
- History of recurrent pancreatitis
- Liver failure or active hepatitis with transaminases > 3x upper limit of normal
- Renal failure or creatinine > 2.5 mg/dL
- Thrombocytopenia (platelets <100,000/mm^3)
- White blood cell count < 2000 / mm^3
- Hematocrit < 30 %
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657618
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657618
|United States, District of Columbia
|Walter Reed National Military Medical Center
|Washington, D.C., District of Columbia, United States, 20307
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Medical Center
|Principal Investigator:
|Roseanne Ressner, MD
|Walter Reed National Military Medical Center, Infectious Disease
More Information
Keywords provided by U.S. Army Medical Research and Materiel Command:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 19, 2017
|Responsible Party:
|U.S. Army Medical Research and Materiel Command
|ClinicalTrials.gov Identifier:
|NCT00657618 History of Changes
|Other Study ID Numbers:
WU#04-19011 ( Other Identifier: IRB )
Pentostam ( Registry Identifier: NCT00657618 )
|Study First Received:
|April 8, 2008
|Last Updated:
|May 2, 2017
Keywords provided by U.S. Army Medical Research and Materiel Command:
Leishmaniasis, Sodium stibogluconate, Pentostam, sand fly
Additional relevant MeSH terms:
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antimony Sodium Gluconate
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiplatyhelmintic Agents
ClinicalTrials.gov processed this record on September 19, 2017


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The first day of school after the Sandy Hook Elementary School shootings in Newtown, Conn., Bloomfield Hills School District officials met with Bloomfield Township police to talk about security procedures.
"The discussion was ground-breaking, wide-reaching," said Capt. Scott McCanham with Bloomfield Township Police.
The meeting centered around security, prompted by the deaths of 26 people gunned down Dec. 14 at Sandy Hook Elementary School in Newtown, one of the worst mass shootings in U.S. history. The gunman also killed his mother in her home, before committing suicide.
That week, the department sent additional officers to patrol the schools -- in case. The district and police officials continued to talk.
On Thursday, Bloomfield Hills Superintendent Rob Glass announced the district and police department have agreed to partner to hire a security officer whose function will be to keep students and buildings safe.
"While we have been reassured our procedures are among the very best," said Glass in a statement, "we also believe that there is room for improvement. The pathway to a higher level of safety and security rests in higher levels of consistent training for staff, students and the parents who frequent our schools. The best plans in the world are dependent upon faithful execution in order to provide the protection intended."
The Bloomfield Hills district has 5,500 students in four elementary schools, three middle schools and two traditional high schools.
A new combined high school was approved last year and is expected to be constructed to open in 2015.
"There is so much there (in the district) to handle,"� McCanham said.
McCanham said he believes the person would be hired before the end of this school year. No firm date was announced.
The district has two school liaison officers who are police officers hired by the township. The district and township split the officers' salaries, said McCanham.
The new security official would work for the district during the school year, said district spokeswoman Shira Good, and then work for the police department in the summer.
The benefits of being a Bloomfield Township officer is that "they will be able to go to (the police department's) roll call and know what is happening in the community," Good said.
The new official will be asked to:
n Conduct an immediate review of existing procedures, identify areas for improvement and help make those improvements.
n Provide ongoing training and drills for staff, students and parents at each building.
n Monitor security on a rotating basis across the district, making sure buildings are secure and procedures are being followed as intended.
n Provide a visible security presence within the district and proactively communicate with the district's two police liaison officers and other area law enforcement to stay apprised of any potential threats that may arise.
Good said questions came up during the in-depth look at security in December and January, and officials found procedures that could be improved.
"We told people to please not hold doors open for (strangers), and to let them know they need to be buzzed into schools," Good said.
"We are encouraging staff to wear their ID badges."
With the new high school in its final design stage, "we want to build that as safely as possible," Good said.�
Safety, she noted, involves more "than an active-shooter situation."
McCanham believes the new hire in the district is a "great idea," he said.
"Job one for this person will be to make sure Newtown stays fresh in everybody's mind."
Contact Carol Hopkins at 248-745-4645 or firstname.lastname@example.com. Follow her on Twitter @OPCarolHopkins or on Facebook @OPcarolhopkins.
Oakland County school staff learns how to protect themselves, students in active shooter training WITH VIDEO

subset: commoncrawl


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Topic: Discomfort when sitting
As many of you know my husband had very severe weight loss. One of the consequences of this was that he had no fat on his buttocks and thighs. He was literally skin and bone. When he sat down, because he had no cushioning he was very uncomfortable. His coccyx ('tail bone' at the base of his spine) had no protection and just to sit for a short time was difficult and painful. Ordinary cushions, rings etc didn't help.
I found a shop that sells support for the back and found a firm cushion with a hole where the coccyx is and it was fantastic. We could go out to eat, to the cineams and even just sitting watching television became possible again.
I'm posting this to help anyone dealing with the same problem as we were looking for a solution for ages and only found this by accident.


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A FATHER from Winchester who took his own life had no previous history of mental health problems, a coroner's court has heard.
An inquest on Wednesday (February 13) heard that Martin Newbold, known to family and friends as Jimmy, hanged himself in the garage of his home at Chalk Ridge, Highcliffe.
His wife, Gemma Newbold, told the court that her husband, a civil servant, had shown no signs that he might take his own life.
"I never, ever thought that he was going to do this. He never ever talked about suicide," she said.
A report from his GP said that he was surprised at his death, since the patient had never presented any mental health problems.
However, the hearing in Winchester was told that Mr Newbold's drinking had caused his wife some concern and he was two-and-half-times the drink drive limit at the time of his death.
But central Hampshire assistant deputy coroner Sarah Whitby, said she was in no doubt he intended to take his own life.
His son Dominic found him hanging on August 31, calling an ambulance before attempting to resuscitate his father.
The coroner said to Mrs Newbold: "His (Dominic's) presence of mind in these circumstances I find quite remarkable for a man of his age and I hope you pass on my admiration."
A verdict of suicide was recorded.


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The Rite Aid store at the Boatyard Shopping Center may be closing, but the pharmacy inside has no immediate plans to close, says Fort Bragg Pharmacy owner Andrew Lien.
Lien said he has received lots of inquiries from patrons since news of the Rite Aid store closure began circulating. He wants everyone to know the closure does not necessarily affect his pharmacy.
In fact, there is a possibility that he may be able to remain open indefinitely at his current location, should some other entity decide to lease the building. In that event, Lien said he might be able to enter into a sublease agreement with that entity in an arrangement similar to the one he has now with Rite Aid.
For more on the story, stay current with the Advocate-News.
The Fort Bragg Pharmacy can be reached at 964-1057.


text:
Plan Review Submission Requirements
Choose from the project types below for specific plan review submission requirements. If you have any additional questions, please call or e-mail Building Plan Review at 703-222-0114, TTY 711.
- Additions
- Carport Enclosures
- Decks
- Finished Basements
- Garages and Sheds
- New Home Construction
- Pools, Spas, and Hot Tubs
- Retaining Walls
- Site-Related Plans
- Sunrooms and Patio Covers
- Woodstoves and Fireplaces


text:
Minor feels good despite recent results
LAKE BUENA VISTA, Fla. -- Kris Medlen and Mike Minor ranked first and second among National League pitchers in ERA after June 30 last year. Over the course of the past week, the two Braves pitchers have provided the reminder that Spring Training results do not serve as an indication of what to expect during the regular season.
One day after Medlen endured his second straight rough outing, Minor followed suit during Monday afternoon's 7-4 loss to the Mets at Champion Stadium. He surrendered six hits, including three home runs, and allowed five runs in five innings.
"I feel good," Minor said. "I feel like I've grown up a lot from last year. If that happened last year, then I would be pretty [upset], with my head down and thinking it was over. I have a lot of confidence and I feel good going into the season."
Minor seemingly turned the corner last year when he produced a 6.20 ERA in his first 15 starts and a 2.21 ERA in the 15 starts that followed. That stretch provided him a sense of confidence that has not been damaged by the fact that he has allowed 14 runs in the 14 innings he has completed since entering the fifth inning of his March 14 outing against the Cardinals with a streak of 12 consecutive scoreless innings.
Minor's struggles in his past two starts have been influenced by his attempt to test the two-seam fastball that he has been trying to develop since the start of Spring Training. After he struggled to command the pitch while throwing it throughout the three-run first inning on Monday, Braves pitching coach Roger McDowell told him to limit his development of the pitch to side sessions between starts.
"I just wanted to throw it the last couple of starts to see if I could put that in my arsenal as the season progresses," Minor said.
Minor's final Spring Training appearance will come on Saturday when he starts for the Braves in an exhibition game against the organization's top Minor League players at Double-A Mississippi's Trustmark Park. His first scheduled regular-season start is set for April 5 against the Cubs.
Mark Bowman is a reporter for MLB.com. This story was not subject to the approval of Major League Baseball or its clubs.


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The Regnum Christi Movement offers its members some guidelines of a gospel-based spirituality as an ideal of Christian life. The spiritual path that Regnum Christi members walk mainly consists in knowing, loving, imitating, and proclaiming Christ. This is the path and these are the goals.
Below, we offer some resources that can help nurture the spiritual life of Movement members and of any Christian.
Daily Prayer 2004-11-27
Listen to podcast version here.
November 27, 2004Saturday of the Thirty-Fourth Week in Ordinary
TimeFather Edward Hopkins, LC Luke 21: 34-36Jesus said to his
disciples: "Beware that your hearts do not become drowsy from
carousing and drunkenness and the anxieties of daily life, and
that day catch you by surprise like a trap. For
that day will assault everyone who lives on the face
of the earth. Be vigilant at all times and pray
that you have the strength to escape the tribulations that
are imminent and to stand before the Son of Man."Introductory
Prayer:Lord Jesus, I believe that you have called me to
fight for your Kingdom. You speak to me and guide
me in the sanctuary of my heart, in the depths
of my conscience. I trust that you will show me
where to wage the battle and give me the strength
to keep trying, despite failures and setbacks. I love you
Lord, because you have given me all yourself on the
cross. Lead me down this path of self-sacrifice and love.
Petition:Lord, grant me the grace of a militant, persevering heart
to fight for the Kingdom.1. Drowsy Hearts. What does it
mean for our hearts to become drowsy? The cause of
this drowsiness is an escapist lifestyle. We were created to
live life and to live it to the full. A
full Christian life is a life of self-giving and sacrifice
for love. This is what our heart was made to
do, give itself for others. Sin and the deviations of
disordered living corrupt and frustrate the hearts action. Instead of
giving to others, it begins to turn in on itself.
A cycle of selfishness robs the heart of healthy renewal;
giving to myself leads to stagnation. Finally, we lose the
ability, or at least the facility, to love. A drowsy
heart is old and tired, grown insensitive to love and
lies isolated in its own self-satisfaction. God is no longer
at the center of a drowsy heart, nor will such
a heart reach out to God when the moment of
tribulation comes. This is the heart whose life of faith
and love has been suffocated by the thorns and brambles
of worldly cares. The frightening fact is that a heart
does not become drowsy overnight; rather a slow process of
self-seeking leads to the final heart attack. How awake is
my heart?2. The Assault of That Day. What will
that day be like for me? It can come suddenly,
like a fatal accident or slowly like a terminal disease.
But that day, which ends life here, comes for each
and every one of us, despite our efforts to ignore
or escape it. It is a violent and powerful assault,
one that tries to rip from us life and love.
Yet, that assault occurs every day as the world tries
to absorb our attention, fog our memory of who loves
us authentically and unconditionally, and entice us to love ourselves
to the exclusion of all other loves. When extreme suffering
and difficulties reach our lives, we hold on to what
is most rooted in us. If that is something temporal
or our own selves, we are lost. We have nothing
to really hold on to; death rips it away. If
we hold on to what is most noble and supernaturally
beyond us, then not even death can take it away.
We are secure in love, for love is stronger even
than death. No one can presume to be strong enough
to handle the greatest trials of life and death. We
are given a lifetime to prepare our hearts well. What
am I doing to prepare now for that day?3. Standing
before the Lord. In the end, we have but one
hope, to stand before the Lord. Those who are not
ready will flee before the Lord. The Final Judgment will
bring us before the Lord. No excuses, no loop holes,
no second chances will be found. We will knowour own
conscience will accuse usif we are worthy to stand before
him. Those who have placed their trust in him and
have sincerely confided in his forgivenessaccusing themselves in this life,
those who have fought to follow him and love him
will stand upright before the Lord. They will stand, not
because they are perfect but because they have fought the
good fight for him, never giving up, and are proud
to have done so. Will I be found standing? How
well do I try to stand before the Lord each
night, after even the worst falls?Dialogue with Christ: Lord Jesus,
awaken my heart to your friendship and the challenges of
bringing your Kingdom to other hearts. Help me to fight
each day to be faithful and overcome the temptations to
selfishness and discouragement. Where am I failing to fight or
compromising my faith? Keep me from self-deception. Teach me to
grow deep roots of virtue that will stand the test
of trial and suffering. Purify and form my conscience so
that I can stand before you each day with confidence,
confident in your grace rather than in my strength.Resolution: I
will place myself deliberately and consciously before the Lord as
I begin my nightly conscience examen.Want to help us maintain
this free service? Make a tax-deductible donation online by clicking
here.This link will take you to
the online donation page of the Legion of Christ, but
accessing it by this specific link will create a report
letting us know your donation is for the daily meditation
service from RegnumChristi.org.Thank you and God bless
The daily meditation is a service of Regnum Christi that offers people a Gospel reflection through e-mail. You can view the weekly meditation on this link or listen the podcast version here.
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text:
|Trad, Aid
|YDS: 5.10 French: 6b Ewbanks: 20 UIAA: VII- ZA: 19 British: E2 5b [details]
|FA: Sibley and Roos 1969
|Page Views:
|Submitted By:
|Andrew Gram on Oct 19, 2001
|RAIN, WET ROCK and RAPTOR CLOSURES: The sandstone around Moab is fragile and is very easily damaged when it is wet. Also please ask and be aware of Raptor Closures in areas such as CAT WALL and RESERVOIR WALL in Indian Creek MORE INFO >>>
|Comments on Stolen Chimney
|Add Comment
|Show which comments —
Comments displayed oldest to newest — Skip Ahead to the Most Recent Dated May 9, 2017
By Dave Chenault
Nov 28, 2001
|Amazing route, justifiably popular. The only real loose rock is on the 5.easy start of the first pitch and at places in the chimney (which is amazing, best chimney I've done, and more like 5.7-). I am pretty sure the chimney is longer than 90 feet, and it is definitely a double-rope rap to the top of the first pitch. Make sure to squeeze through the hole under the chockstone at the end of the chimney, it will remind your partner of all the beer he drank the night before.
By Steve "Crusher" Bartlett
Jan 1, 2002
|Great climb! One of the best. Be careful; last time I did this I cracked (loudly!) a rib while manouvering my fat carcass onto the diving board. Finished the route but could not climb again (or sneeze) for weeks. Descent tip: If you have two 60 meter ropes, you can rappel from the big ledge at the top of the chimney all the way to the ground, into an alcove left of the first pitch. This rappel is about 57-odd meters, so be careful!
By Aaron Shupp
Feb 5, 2002
|The best method for getting onto the diving board on the last pitch is the "jump 'n' hump" method (self explanatory). As in similar exercises, finess not force will bring about the most pleasing results.
By Charles Vernon
From: Tucson, AZ
Feb 23, 2002
You can do this climb in 2 pitches if you use a 60 meter rope and scramble the ledgy initial section of P1. The first pitch would be a very long link-up of the chimney with both bolt ladders, however this does present a lot of rope drag if you're trying to free the second bolt ladder. After the ascent (the first time on it, we did the standard 5 pitches and 4 rappels), we were able to rap (2 60-M ropes) all the way from the "sidewalk" down to a stance left of the first pitch. From there it was an easy scramble back to the packs, making for a fast round-trip.
Yes, the rock is a bit crumbly, but the moves on every pitch were suprisingly, really fun and somewhat thought-provoking. I can't say that any of them really seemed to be 5.11, though, but erosion may have something to do with that.
By Anonymous Coward
Feb 23, 2002
|Hope I didn't sound too cavalier in the last comment. Just to clarify, the stance where the rappel ends and the ensuing scramble are low-5th class-ish; if you felt comfortable scrambling the first 5.4 section, they shouldn't be a problem.
By Casey Bernal
From: Arvada, CO
May 30, 2002
I would suggest to take a very light rack. The climbing is easy and the gear is only where you need it. Take a set of medium and large stoppers, and #1,#2,#3 cams. Maybe add a few hexes or tricams if you are timid. Take only 4 QDs and maybe 6 shoulder length runners. You can also just take runners and triple up 4 of them for the bolt ladders. Somewhat of a casual route with fun climbing. The crux sections are short and easy to pull through if need be. The drilled pins on the ladders are close together so a fall onto any of them should hold. The second bolt ladder has a newer second bolt which gives some confidence if you are trying to free it. Surely an unforgettable summit. Awesome.
Also- Does anyone know how long the summit block has been loose? I was noticing that if the block was pulled off could possibly cut the summit anchors. yikes be careful
By George Bell
From: Boulder, CO
Sep 3, 2002
|When seconding the final pitch, be careful not to have the belay rope run directly to the summit anchors. During lowering, this puts considerable sideways force on the summit block. Perhaps it is solid but I had a frightening vision of the whole thing toppling. Clip the rope to the summit anchors to you when you head to the diving board, then clip it to the anchor near here so that the rope pulls straight down on the summit anchors (my recommendation anyway).
By Ben Mottinger
Founding Father
Sep 30, 2002
rating: 5.10b 6a+ 19 VII- 19 E2 5b
3 stars for the position and craziness but 1 for rock quality.
I felt the first BL and last were similar in grade and easy to clip up.
By Stan Pitcher
From: SLC, UT
Oct 21, 2002
|A really fun route! A single 60m rope will get down from the big ledge with 2 raps.
By Colin Coulson
Mar 17, 2003
|For the first pitch, it is possible to move left of the popular line to reduce drag. If the leader moves left immediatly from the belay ledge (between a massive boulder and the rock - a bit of a squeez) to a second spacious ledge, the line is directly below the first bolt ladder. Just a thought. Also, after the diving board it is wise to clip the side-by-side pin and bolt with a generous sling to reduce rope drag and lessen the chance of pulling the hardware right out of the rock.
By George Bell
From: Boulder, CO
Apr 14, 2003
Great route! Seemed less grubby than my ascent 8 years ago, I think all the traffic is cleaning off the route.
I discovered you can avoid the diving board belly flop by climbing below it on the left. Perhaps, however, one should not avoid this classic thrutch move. The move off the diving board is the hardest on the final pitch, I think. It's a balancy stem and there are no positive downward hand holds.
We did both bolt ladders free and I agree, I don't think either of them are 5.11. I think they are both 10ish, with the second seeming a littler harder, although shorter. I'd recommend a screamer QD or two to ease the mind of falling on those bolts. Wow, scary image of Jimmy Dunn down free soloing the second ladder!
For good summit shots a wide angle lens is recommended, 28mm or even shorter (35mm equivalent).
By George Bell
From: Boulder, CO
Apr 15, 2003
|I should mention that the diving board avoidance route is possibly more terrifying than the diving board belly flop. At least, there is no pro and potential for a monster swinging fall on lead if a foothold crumbles. However it is probably only 5.6. For the final pitch itself, the leader need only take a long sling or double (as mentioned above) plus a couple QD's and maybe one regular sling. Having no fear of heights also helps.
By Holly Barnard
Apr 21, 2003
|Super fun route and super busy. Be prepared for lots of other parties and don't be a jerk when sharing the route. On the last pitch, the 2nd bolt you clip (ignoring the old belay at the base of the diving board)looked pretty manky too me, but with the advise of the party before us, I backed it up a #3 camalot. It inspired a little more confidence. There are lots of drilled angles and bolts at the last belay. Be advised to position yourself carefully when belaying the leader on the last pitch on the off chance that they take a ride off the diving board.
By Anonymous Coward
Oct 5, 2003
Some Beta for Someone who has never climbed the route and is planning an ascent:
Slings wrapped around summit are two 1" pieces of webbing which seem old to me, and a piece of old 10MM rope. If you go up please bring another piece or two of webbing or rope, these should really be replaced, my partner cleaned the route then I lowered him off the slings and he could hear them creaking. There is alot of UV beating on those slings.
Looking under the summit plate is also an eye opener, there is a lot of air.
We did a short rap from the sidewalk belay to top of the chimney, then a 195ft rap to the base.
Be careful up there, It's an adventure climb that should not be missed!
By Max Schon
Dec 19, 2003
Last time I did this route, we did it in two pitches. We soled up to the first bolt ladder and set up a belay there. Then we blasted all the way to the sidewalk. The first set of bolts is 5.9 and the second set is 5.10ish.
It's possible to rap with a single 60-meter rope. Rap from the big ledge about two thirds down the chimney to an anchor and from there rap to the ground, just barely.
By Vince Romney
Oct 11, 2004
rating: 5.10c 6b 20 VII 20 E2 5b
|Killer tower route in range for most competent trad leaders. Definitely think 5.11 is a bit over-the-top. Maybe hard 5.10, and only a couple of moves while freeing the bolt ladders. Someone commented on using a screamer or two if freeing the bolt ladders... no doubt that would have made it less sphincter constricting, they're pretty manky. Otherwise, not a bad day out even in hideous winds which drove sand into every crevice of my body.
By Rob Dillon
Mar 5, 2005
|FFA: Keith Reynolds & Burton Moomaw, North Carolina water-groove specialists. If these guys had put it up there'd be one bolt on each of those A0 gutters...
By Bo Johnston
Apr 7, 2005
rating: 5.9+ 5c 17 VI 17 E1 5a
|Just climbed this last weekend. 1.5 hours from rope-up to coiling the rope after the rappel. There is no climbing harder than 5.9+ on this route and the bolt ladders are really not scary at all! The crux, for me was the first move up the spire after clipping the first piton. Why is there a belay at the base of the spire??
By John Peterson
Feb 19, 2006
rating: 5.10 6b 20 VII- 19 E2 5b C0
I'd say that the rating is very dependent on height, particularly the second bolt ladder. I found it easy (being tall) and my partner had a much harder time. The initial bolt ladder was similar in difficulty but both of us climbed it very differently.
We were a bit worried to hear that the first of the 3 bolts in the second ladder was an old one but it turns out you don't really make any hard moves before clipping the 2nd bolt (the new one).
The scary part is the final spire - I'd take both a #2 and #3 camalot - they both go about the same place but in this rock I'm of the "two nuts are better than one" theory.
All of the cruxes were very clean. A bit of mud in the chimney but not insecure at all.
[Hey - I can't seem to get the A0 to go away in the rating when I submit my rating! Call technical support!!! Oh - and tell your spell checker that camalot is a real word ...]
By grega Albrechtsen
Apr 26, 2006
|How's this route for the second? Namely coming off the summit back to the belay.. Isn't there the opportunity for a huge swing? :-)
By Andrew Gram
From: Salt Lake City, UT
Apr 26, 2006
The second lowers to the sidewalk and creeps back across. You wouldn't want to fall off the sidewalk in either direction, but you would have to actively try to come off.
Its not a good route to take a rank beginner up, but any climber who is OK with exposure should be fine following it.
By Legs Magillicutty
From: Durango
May 22, 2006
When lowering the second off of the top back to the sidewalk, have the second clip a draw to the rope (the belayers side of the rope) and back to their harness. The belayer can keep the rope tight until the second reaches the sidewalk. As the second begins to traverse back, the belayer feeds out slack allowing the second to walk across the sidewalk while hanging onto the belayer side of the rope, without being pulled but still being somewhat supported. If they are at all nervous about swinging, I found this to be the best method.
Next time I'm up there, I need to have more jump and less hump on that diving board move. :-) The route was fast and fantastic. I don't get why anyone would want to count the sidewalk as a pitch. It seems like belaying from the diving board would be awkward and slightly unnerving while the second comes up with feet flailing. Not to mention the photo ops wouldn't be as good.
By Adam Stackhouse
May 23, 2006
George wrote ""Perhaps it is solid but I had a frightening vision of the whole thing toppling""
Gosh it sure looks like it could fall over in a few places. I remember seeing a pic in an old climbing magazine of some female climber on the top of this bizarre formation.
By Legs Magillicutty
From: Durango
May 26, 2006
|Before I climbed the route, I actually had a dream that I broke Ancient Art. In my dream the last pitch was only about 10'. I wrapped my arms around it, crushed it and watched it fall to the floor below. I giggled a bit about that dream when I saw how solid that last pitch really was.
By RoadTripRyan
From: Salt Lake City, UT
Sep 18, 2007
|We did this route September 17-2007. Wild exposure on the last pitch. If you have a 70M rope, you can rap the route with that instead of taking 2-60M's. 1 set of cams, 1 set of nuts, and some trad draws is the rack we used. My more detailed trip report is here
By Aeon Aki
Oct 14, 2007
rating: 5.10 6b 20 VII- 19 E2 5b
|Descent Beta: 2 60m ropes tied together will get you to the ground from the spacious ledge above the chimney.
By Jake Entin
From: Boulder, CO
Oct 23, 2007
|I submitted a picture about a two years ago that shows how the do the rap with two 60m ropes. From the big ledge above the chimney at the top of Pitch 2 it is possible to rap with 2 ropes outside the chimney. However, it's important that you rap outside the chimney otherwise your ropes will get stuck. This brings you to the ground just left of the start. (SEE BETA PICTURE ABOVE)
By jhump
Dec 21, 2008
|Not sure this was really 5.10; ok maybe 5.10 minus. Felt worlds easier than the Easter Island bolt pitch (Bridger Jacks), which I consider real desert 5.10 face. The people I encountered on route did not even consider free climbing the bolt ladders, which is odd because the ladders are gym style bolt protected (maybe even tighter) and not hard. They are comprised of a really neat mix of cobbles and sandy little slopers and pockets. The technique was to reach up, brush, brush, brush with the fingers, then pull. By the time your second comes up, they will need to brush too. The summit is beyond words. A competent party with no crowd can summit in an hour. A competent party with 2 parties ahead can count on 6 hours and lots of trundled chimney matter to dodge.
By mtoensing
From: Boulder
May 16, 2009
rating: 5.10+ 6b+ 21 VII+ 20 E3 5b
|one 70 meter will get you to the ground
By Mike
From: Phoenix
Jul 9, 2009
rating: 5.10- 6a 18 VI+ 18 E1 5a
|Although most of this route is marginal at best, the last pitch makes up for it and then some. The next-to-last pitch is pretty decent also.
By goatboywonder Patrick
Nov 24, 2009
|There is a pretty nasty death block at the top of the chimney pitch on the climbers left. It looks like a perfect flake to throw a runner over to protect the last move onto the belay ledge (I did it the first time). However, upon closer inspection you are able to wiggle the whole thing like a loose tooth. Be careful with it! If it goes, it will probably tumble down the chimney right onto the belay. I chalked a giant X on it. I am also going to add a pic of the block in the gallery with Brent happily yarding on it before we discovered it was loose.
By Paully
From: Green River, WY
Mar 20, 2010
after a storm last week, a large block that used to be part of pitch 3 fell over and is looming over the chimney. It was the block that formed a crack along the arete that you could plug a cam in. It is not the block that was mentioned in the previous post. It is about 2ft by 2ft by 8ft boulder. There is now a 20ft run-out from the belay ledge to the first bolt. You are looking at probably a factor 2 fall with your rope dragging over the ridge and the new chock-stone if you pull off any of the freshly exposed cutler.
Half of the block is chocked between the arete and the boulder that was already chocked in the chimney. It looks fairly stuck there, but if it comes down there will be carnage in the chimney.
A new bolt hopefully will end up lower on the arete and maybe that boulder could be secured somehow. The climb is still a mild fisher towers experience, though.
By David A
From: Amsterdam, Netherlands
Apr 5, 2010
|Has anybody been up the route since the block has come off?
By bheller
From: SL UT
Apr 5, 2010
Yes and it is totally casual. The boulder should be respected, but will very unlikely depart from its position, and the addition of a new bolt would be ridiculous.
If you solo the first 5.6 scramble, you can get to the sidewalk in 1 pitch with a 70m rope. Nuts, many 24" slings, 8 draws, and a single set of cams from fingers to a #3 camalot is enough gear for
anyone on this climb, even a total beginning leader. 1 70 meter rope gets you down, but one needs to use care to downclimb to the anchor at the top of the 1st bolt ladder about 10 feet- it is dirty, but not exposed nor difficult.
By Daniel Max Christiansen
From: Green Bay, WI
Jun 18, 2010
rating: 5.9+ 5c 17 VI 17 E1 5a
|getting on to the diving board was the freakiest part for me
By Petsfed
From: Laramie, WY
Aug 2, 2010
rating: 5.9 5c 17 VI 17 HVS 5a PG13
|If you're bringing two ropes, you should rappel outside of the chimney (basically straight down the exterior of the tower) rather than down the route. Otherwise, the process of pulling the ropes risks kicking a lot of crap down onto people below. Personally, I've always done the route as two parties of two, then just hung out on the belay ledge while the second party did their summit. Then the descent is pretty well idiot proof. Just one REALLY long rappel.
By NickP
From: Golden, CO
Aug 19, 2010
rating: 5.10- 6a 18 VI+ 18 E1 5a
I found a camera at the base of the first pitch a couple weeks ago. PM if its yours.
On a different note, the climb is amazing. It's probably the best climb in the universe for the 5.10 sport leader who is getting into trad. Enjoy!
By Josh Cameron
From: California in my Mind
Jun 12, 2011
rating: 5.10 6b 20 VII- 19 E2 5b
|A wild desert adventure. Had so much fun that since noone was behind us, we climbed the summit twice. On the second pitch, whenever things get hard, think stemming.
By John Martin
From: Kearns, UT
Jan 7, 2012
|This is where they filmed a Citi commercial, the video looks great: cnn.com/video/?/video/us/2012/...
By Ryan Strong
From: Golden, CO
Mar 29, 2012
rating: 5.10 6b 20 VII- 19 E2 5b
|We were able to rap the sheer face straight to the ground with two 70M ropes. I am not sure if this is recommended due to the crumbliness of the face , but it was a good way to avoid jamming up other parties had we rapped the route.
By Topher M.
From: moab, ut
Mar 31, 2012
|After rapping down from the sidewalk belay, you can rap all the way to the base (from the top of the chimney) with two 60m ropes!
By Topher M.
From: moab, ut
Apr 24, 2012
Thank you to all who helped in rescuing a fallen leader yesterday. Great inter-agency cooperation. Thanks to GCSAR, NPS Tech Rescue, Life Flight, Grand County EMS, and everyone else that chipped in. Hope our patient makes a full and speedy recovery.
Be careful up there! This is a desert tower after all.
By Stefanie S.R.
May 6, 2012
|Climbed it on May 2 right after ALL THE BOLTS WERE REPLACED! Big thank you to the guys that were out there and making a fun classic safe for people to climb again.
By Sam Lightner, Jr.
From: Lander, WY
May 7, 2012
|Don't worry... you can still fall and get hurt or killed... easily.
By Sam Lightner, Jr.
From: Lander, WY
May 7, 2012
Hey Jeremy
OK, here is the history as I have it... its all in the beholder of course.
A few years ago Josh Gross and I went out there and redid much of the route with stainless rawls where there were banged in angles and star drives. Nothing added, just replaced. Since then one of those rawls, sorry Powers 5 pieces, looked as if it had unscrewed on its own (perhaps) and come out.... another, on pitch 3, looked to have been removed. Again, these were just replacements of what had been in there... nothing added. So, people talked worriedly about the bolts unscrewing and I hate the thought that this is happening, especially with the cost of the bolts. Then that big block that you used to get cams behind on the approach to the arete of pitch 3 collapsed. Then that girl tumbled a few weeks ago trying to get to the first bolt past said broken block.
So Larry Harpe and i went out and redid those bolts that Josh and I redid a few years ago plus put one in where the collapsed flake once was. We also redid the two angles on the last pitch. One of these gets pulled down and across in a fall and then straight up on when you lower off from the summit block... not a good place for an angle, especially since its generally everyones only piece of pro to get on the corkscrew. Anyway, we replaced the already replaced bolts with glue ins and the replaced two that protected the actual cork screw of the last pitch. We also added a bolt where the big flake used to be and where you have to crawl across the blocks to reach the arete.
And thats that. As most will point out, I am a steady supporter of the "Bolt it like the first Ascentionists did" approach to replacement. The added bolt in this case is because the placements the FA guys had are gone now.... the whole flake fell away. The only other option there is to place it in a flake roughly the size of a suitcase that is just a rock resting on some mud. This is the spot the girl fell.... I'm sure, considering the way the bolt ladders originally were, that the FA guys would have done this as well.
Have at it...
By Lspade
From: Maplewood, MN
May 11, 2012
rating: 5.10 6b 20 VII- 19 E2 5b
Good to hear they put in some new protection!!! I was part of the group with the fallen climber. Here is the story:
Me and three friends (I will refer to them as friend 1, 2, and 3) set off on April 23 to climb Stolen Chimney. Friend 1 and 2 were climbing together and Friend 1 was supposed to lead all of the pitches because friend 2 only sport leads. Me and friend 3 were climbing behind them with me leading all of the pitches. Friend 1 and 2 were both on the third belay ledge as I started leading up the dirty chimney of pitch two. When I was half way up the pitch I heard this really loud scream. All of the other partys on the ground went into emergency mode and I finished the pitch to find climber 2 laying on her back with a cracked helmet.
Climber 1 told me that he suggested to climber 2 that they should rap down since pitch 3 was so run out and exposed but climber 2 begged to lead it since there was no trad gear needed. She peeled off while trying to clip the bolt and pushed off backwards landing on the belay ledge. She was in too much pain for us to lower her to the ground so Search and Rescue was called. We told friend 3 to pull the rope and rap to the base. First EMT jugged up our fixed line, second EMT led up the route using my gear placements, first park rescue jugged up the fixed line, second park rescue jugged up the fixed line, third EMT jugged up the fixed line. That means there were 8 freaking people on the belay ledge! After five hours of crazyness a heli medic from Salt Lake City was lowered onto the belay ledge. He had no problem hanging under a flying helicopter but as soon as he was dropped off on the ledge he was terrified! We were all amused by that. He flew away with her in this netting thing and the rest of us rapped down. She had 4 broken ribs and a brain bleed but is expected to be out climbing hard soon!
Everyone agreed that she would likely not be here if she had not been wearing her helmet. Be careful guys and thank you again to all of the Rescue crew who helped save her life!
By Sam Lightner, Jr.
From: Lander, WY
May 12, 2012
I feel compelled to say this:
Ancient Art's Stolen Chimney is NOT a sport climb and should not be attempted by any climber who is not very comfortable climbing 5.10. There are places on each pitch where if you fall you will likely die. At the very least you will be badly hurt. The replaced bolts are nothing more than than a modern version of what the original ascent party had. They can be manipulated with by people, or damaged by the elements, in such a way that they are not safe. For this reason any climber attempting this route, or any other non-sport climb for that matter, should assume that their most trusted piece of protection is their ability to NOT fall. Climbing is dangerous. Its even more dangerous in the Fisher Towers. Do not approach this route with a sense that it is easy.
By slim
May 12, 2012
rating: 5.10c 6b 20 VII 20 E2 5b
|i feel compelled to say 'ditto'. i've been somewhat horrified by some of the folks i have seen on this thing. i think one of the problems is that it has become a bit of a circus with guides and unprepared/incompetent clients, which has given it kind of an 'anybody can do it' sort of reputation. as sam has said, there are several places on this route where you absolutely don't want to fall.
By Topher M.
From: moab, ut
May 14, 2012
Well said Larry. Besides the rescue, I've helped prevent several serious accidents by private parties while I was guiding clients. I haven't seen any issues with any professionaly guided parties.
Be careful out there everyone!
By slim
May 14, 2012
rating: 5.10c 6b 20 VII 20 E2 5b
you both make good points, and i definitely shouldn't point all or even most of the blame at guides. i apologize. my comment was based on climbing in the area several times when there were multiple groups on AA that had (or appeared to have) 1 guide and 2 -4 clients. one day in particular i counted 9(!) people at a single belay. and the people that i saw in the group were obvious beginners (ie needed very close instruction on all aspects of the climbing, including rapping, etc).
anyway, all that aside - thanks to the guides who helped the young lady with the rescue, and hopefully people will be careful up there.
By Ryan Barber
From: Rumney, NH
Sep 20, 2012
|Redpointed it the other week. The 5.10 technical faces took me a few moments to figure out the right sequences and pressure points. Also, it looks like there are a few retrobolted sections including the crux move getting onto the corkscrew making the climb feel much safer than last year.
By Dwight Jugornot
From: Arvada, Co.
Sep 20, 2012
4 stars, 3 of which are garnered by the summit. No need to aid the bolt ladders, the moves are all there and well protected. There is now another bolt where the female climber whipped and helicoptered , thus it is quite well protected now.
If you hear a buzzing/crackling sound near the top bail immediately as you are about to get struck by lightning. I felt sparks arcing off of my shoulders and forearms. This thing is an antenna. Never saw any lightning, but it musta been close. Only very light sprinkles.
Yes, this seems obvious to me now. I just didn't realize you would ever hear any noise before you exploded like a gnat in a bug light.
By Geir
From: Tucson, AZ
Oct 31, 2012
rating: 5.10c 6b 20 VII 20 E2 5b
|A classic route with a spectacular summit. One I will never forget!
By dgelman
Apr 7, 2013
|I climbed this in late 2000 at age 62/63 (as a 2nd) and found to be a great climb if rather a different sort of rock for me. The next year I had a mild MI and a stent. My blocked artery no doubt affected my climbing at the time I am okay now with the stent, Meds, etc; and still climb at 75. The climb appeared to be 5.8, A0 for me. The exposure was great fun I sat on the top rather stand on it which did not occur to me then J. Dunn who I spoke to at the bottom watched me climb and said I was fine but forgot to take a photo as he said he would. No big deal the compliment was enough wish I could climb cottontail.
By JacobK
May 28, 2013
Climbed this past Saturday. All bolts are in good condtion.
In regards to the final pitch, I had been told it was not a good idea to top rope the section after the sidewalk and am not sure why this is. The majority of this section puts you directly under the anchor. The final move does require you to move around the side and feed some slack but would still be a relatively minor swing should a fall occur. A quick draw can be left on the bolt just below the anchor should there be a timid climber in the group that can be utilized to make this a relatively simple move. Regardless crossing the sidewalk is still the most dangerous part as a top rope doesn't really provide any more protection then leading it.
By Jordan Hirro
From: Colorado Springs/Carbondale
Oct 2, 2013
|Absolute must. In my opinion, the chimney and .10 face climbing really isn't the greatest...but the topout is undoubtedly the best around. I'll do the chimney over and over just for the topout. It's that good. Single rack from .4-2 or 3 with about 8 draws. We got lucky and were alone so we only brought 1 70 and did the whole thing in 1 pitch from the scramble. Then jut make 3 raps from the sidewalk and you're set to jet!
By Kevin Bradford
Oct 9, 2013
rating: 5.10b/c 6b 20 VII 20 E2 5b
|This thing is worth the crowds and mud, super unique experience. The free climbing through the first bolt ladder felt like 10+, using shallow pockets and pinching pebbles embedded in the mud to move through a slight bulge. The 5.8 mud chimney was surprisingly fun by all accounts. We actually waited for over an hour at the top of this pitch for 3 base jumpers to finally leap from the sidewalk. It was cool to watch and we had planned on being stuck in lines, so no worries. Second bolt ladder felt easier, maybe 10-
By Floridaputz
From: Oakland Park, Florida
Mar 12, 2014
|The Fisher Towers is an fantastic place. Well worth a visit on it's own. To go there and get to stand on top of Ancient Art is really cool. Yes, the towers are made of mud. It is a bit unnerving climbing on this type of rock. I used a point or two of aid.
By DennisL
From: Bishop, CA
Apr 23, 2014
Absolutely must-do!! Accept the fact that sharing the route with others is part of the experience, make friends with them, and have a great time chilling at the belays watching others summit and rap!
Pull the rope and re-lead the summit pitch - definitely safer and good for bragging rights!
By Justin Skaare
From: Boulder, CO
Apr 30, 2014
|Because of the popularity of this climb I'd suggest a double rope rappel instead of a 70m just to be courteous of other groups in queue.
By Ian Colquhoun
From: New Jersey
Jun 24, 2014
rating: 5.10b/c 6b 20 VII 20 E2 5b
My first multi-pitch climb and wow! amazing exposure and some awesome climbing! I found the first bolt ladder at the end of P1 to be slightly more difficult than the second on P3, but thats only due to it being a lot longer.
I personally found the chimney to be an awesome pitch, and at the top of it when the "back" goes away and the wind picks up you have a major pucker moment!
Wide high right foot stem on the way up off the diving board and one last hardish 5.9 move on the back of the corkscrew and poof: best summit for me yet!
By Jim Fox
From: Westminster, CO
Mar 25, 2015
rating: 5.9+ 5c 17 VI 17 E1 5a PG13
Great summit in an awesome setting.
Yes, it's dirty and the rock is basically dried mud but it's a fun climb from the start and has a couple 5.9+ or 5.10 sections. Mostly easy climbing but pro is a little sparse. The mud chimney was mostly fun- I stayed on the outside and stemmed mostly. Was forced deeper into the chimney near the top and scraped my way up the last 10 feet. The summit is the real reason to do this climb and it was as exposed and crazy as it looks, FUN!
By George Bell
From: Boulder, CO
Apr 21, 2015
|Does anybody know why this chimney is called "stolen"? Did Sibley and Roos steal the FA from under Harvey Carter's nose, or what?
By Dan McCabe
Jun 8, 2015
|Climbed it this last Wednesday (6/3) with my 15 year old son. He couldn't get out a #2 cam, so I was going to get it on rappel. There were 2 guided parties on the route and I informed everyone that we had left the gear behind. Now, I understand that booty is booty, but I was very surprised that someone took the cam and didn't say a word. Given the circumstances and my sons age, that's just bad form!!!!
By eldoradolocal
Jul 23, 2015
|Apparently Carter thought so. He named the route.
By Michael Dom
From: Seattle
Dec 22, 2015
rating: 5.10 6b 20 VII- 19 E2 5b
|Mega busy route. The prize is the top of the pitch when you summit that spindly spire. I think this is a must do climb if you are in the desert and can wake up early enough to beat the crowds.
By Kevin Dahlstrom
From: Fort Worth, TX
Mar 18, 2016
|Incredible route. Obviously the summit is amazing, but the climbing itself is surprisingly fun and engaging the whole way. The lower bolted crux is 10a and the upper is 10c (but only one move). Be prepared for crowds of climbers of questionable competence and long waits at each belay - but this is one route that is worth it.
By Haley L Young
From: Boulder, CO
Mar 28, 2016
rating: 5.10 6b 20 VII- 19 E2 5b
|I would recommend coming VERY early if you do not want to wait in line all day to climb this amazing route. It gets VERY backed up. Very heady and exposed climb especially on the cork screw. Second pitch and top out are AWESOME! The hike in is beautiful as well. My partner and I arrived just about sunrise on a weekday and were the first to ascent that morning.
By Nick Black
From: Arcata, CA
Apr 18, 2016
|Rock is way better than the average desert tower, don't worry about it!
By John Binger
From: Moab, UT
Jun 7, 2016
|Did this route today. The anchors at the beginning of the "sidewalk" have 2 loose bolts. Take a wrench and tighten them up if you have one!
By Mike A. Lewis
From: Estes Park, CO
Oct 15, 2016
|This climb has become very popular - so we need to be considerate of other climbers and how long we take to climb this route and make space for others to do the same. On any popular, moderate routes, I believe climbers should generally be climbing in parties of two, unless they are very experienced climbers who have the skills to manage a group of three quickly and efficiently. Parties of four - no way (unless there is no one else around)! When you get to the Sidewalk and the Tower, please climb, get your photos, and get down... so other people can get up there and have their fun too. By the way, the slab of stone on the summit heavily vibrates on testing - it's not going to be there forever!
By Scott
From: Colorado
Mar 10, 2017
rating: 5.10 6b 20 VII- 19 E2 5b
|Are two ropes required for the rappels?
By Hobo Greg
Mar 28, 2017
|In response to the comment in the route description "there are places on each pitch where if you fall you will likely die"; OH CMON! Both face pitches are French freeable, let alone well protected for lead. As for the chimney, there's so much pro, in decent enough rock, that only a fool would be able to get killed there. Perhaps the only spot where you can truly get messed up is the sidewalk and diving board mantel, but those are both really easy. I don't consider myself a solid 5.10 leader (look at my ticks), but I had no problems at all with this climb. Maybe the person who submitted the route just wants to keep the crowds away ;) If you show up a few hours before sunset, most of the crowds have come and gone, and you can top out with stellar lighting to accompany the stellar view. Gear: nuts, cams .5-2 Camalot, draws.
By Derek Michael
May 9, 2017
|Bit of a zoo. My girlfriend literally stepped on the hand of some asshole who started leading the chimney pitch as she was still following and cleaning it. Otherwise an amazing climb. It's possible to rap with a single 70m rope, but people will hate you less if you bring a second rope and stay outta the chimney.


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Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis
Recruitment status was: Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
|HIV Infections Tuberculous Meningitis
|Drug: Combivir and efavirenz
|Study Type:
|Study Design:
|Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:
|Randomised Controlled Trial of Immediate Versus Deferred Antiretroviral Therapy for HIV-Associated Tuberculous Meningitis
- Mortality [ Time Frame: 9 months ]
- Mortality [ Time Frame: 12 months ]
- Fever clearance time
- Coma clearance time
- CD4 count [ Time Frame: 12 months ]
- plasma HIV RNA [ Time Frame: 12 months ]
- Grade 3 or 4 adverse event [ Time Frame: Any ]
- Neurological disability [ Time Frame: 12 months ]
|Study Start Date:
|September 2005
|Estimated Study Completion Date:
|December 2008
|Estimated Primary Completion Date:
|December 2008 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: 1
Combivir, efavirenz for 12 months
Drug: Combivir and efavirenz
Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months
Placebo Comparator: 2
Placebo for 2 months followed by Combivir and efavirenz for 10 months
Drug: Combivir and efavirenz
Arm 1: Combivir and efavirenz for 12 months Arm 2: Placebo for 2 months then Combivir and efavirenz for 10 months
Detailed Description:
Title: Study of immediate versus deferred antiretroviral therapy in HIV-associated tuberculous meningitis Study design: A randomized, double blind, placebo-controlled trial with 2 parallel arms Sample size: 247 Inclusion criteria: Age 15 years or older; HIV antibody positive; clinical diagnosis of TBM.
Exclusion criteria: positive CSF Gram or India ink stain, known or suspected pregnancy; antituberculous treatment 8 to 30 days immediately prior to recruitment; previous antiretroviral therapy; laboratory contraindications to antiretroviral or antituberculous therapy; lack of consent.
Consent: Written informed consent will be sought for all patients. Verbal consent will be considered acceptable when written consent is impossible. In unconscious patients, the consent of 2 independent physicians will be considered acceptable.
Randomization: Patients will be stratified according to TBM disease severity at presentation (modified MRC grade I to III). Within each stratum, patients will be randomized to 1 of the 2 treatment arms: immediate or deferred (2 months) ART.
Antituberculous treatment: Initial therapy will be with isonazid, rifampicin, pyrazinamide and ethambutol for 3 months. After 3 months, patients will continue on rifampicin and isoniazid for a further 6 months.
Corticosteroid treatment: Dexamethasone 0.3 - 0.4mg/kg will be administered and tapered over 6 - 8 weeks, according to TBM grade.
Antiretrovira l treatment: Antiretrovirals (zidovudine, lamivudine and efavirenz)or identical placebo tablets will be commenced at study entry and continued for 2 months. Thereafter, all patients will received antiretrovirals.
Clinical monitoring: Patients will be assessed weekly as an inpatient for 3 months. Hospital outpatient review will occur monthly until 9 months. A final follow-up visit will take place at 12 months.
Laboratory monitoring: Routine laboratory tests will be monitored weekly as an inpatient and monthly as an outpatient. Blood samples for CD4 T-lymphocyte count and plasma HIV-1 RNA level will be monitored 3-monthly. CSF samples will be taken at 0, 1, 2, 3, 6 and 9 months.
Radiology: Patients will have a chest radiograph performed on admission. A CT or MRI brain scan may also be performed if clinically indicated.
Adverse events: All grade 3 and 4 adverse events will be reported immediately to the Data and Safety Monitoring Committee.
Outcome measures: The primary endpoint will be mortality at 9 months. The secondary endpoints will be: mortality at 12 months; fever clearance time; coma clearance time; neurological relapse; progression to new or recurrent AIDS defining illness; any grade 3 or 4 adverse event; CD4 count response; plasma HIV-1 RNA response; neurological disability.
Data analysis: Analysis will be based on intention to treat.
|Ages Eligible for Study:
|15 Years and older (Child, Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- age 15 years or older
- HIV antibody positive
- clinical diagnosis of TB meningitis
Exclusion Criteria:
- positive CSF Gram or India ink stain
- known or suspected pregnancy
- antituberculous treatment 8 - 30 days immediately prior to recruitment
- previous antiretroviral therapy
- laboratory contraindications to antiretroviral or antituberculous therapy
- lack of consent.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433719
|Hospital for Tropical Diseases
|Ho Chi Minh City, Vietnam
|Pham Ngoc Thach Hospital
|Ho Chi Minh City, Vietnam
|Principal Investigator:
|Estee Torok
|University of Oxford
|Responsible Party:
|Centre for Tropical Diseases, University of Oxford
|ClinicalTrials.gov Identifier:
|NCT00433719 History of Changes
|Other Study ID Numbers:
|Study First Received:
|January 25, 2007
|Last Updated:
|August 6, 2008
Keywords provided by University of Oxford:
Human immunodeficiency virus
Tuberculous meningitis
Treatment Naive
Additional relevant MeSH terms:
HIV Infections
Tuberculosis, Meningeal
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Central Nervous System Diseases
Nervous System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Tuberculosis, Central Nervous System
Central Nervous System Infections
Lamivudine, zidovudine drug combination
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
ClinicalTrials.gov processed this record on September 21, 2017


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Editor's Note: In this great city of ours, one could eat a different sandwich every day of the year--so that's what we'll do. Here's A Sandwich a Day, our daily look at sandwiches around the Windy City. Got a sandwich we should check out? Let us know!
Americana Submarine is steps away from the row of fried food featured on Lunch in the Loop, like Micky's Chicken and Fish and Coco's Famous Deep Fried Lobster. But unlike those restaurants, nothing on this menu is fried. When I asked what the most popular sandwich on the menu was, the cashier proudly exclaimed that it was the ominous sounding "Bomber."
The Bomber ($7.29 for 12" sub) is comprised of ham, spiced loaf (which is still somewhat of a mystery to me), Genoa, hard and soft salami, and when ordered with everything includes cheese, lettuce, tomatoes, onion, and sub sauce, which is basically Italian dressing. Hot peppers, rather than giardinera, come in the form of pickled jalapenos, which work surprisingly well at adding a pickled flavor to the pile of otherwise dense, salty, and fatty meat. It's all carefully stacked between Italian bread that's both chewy and soft at the same time. This is an uncomplicated and easy sandwich, but it's a quick fix if you're in a lunch rush downtown.
400 S. Clark Street, Chicago IL 60605 (map)
About the author: After a failed attempt at starting a chain of theme restaurants called "Smellen Keller," Dennis Lee traveled the world to discover his true passion. Sadly, midwifery didn't pan out. Now he works in a cubicle, and screws around as much as possible. Follow his shenanigans on Twitter.