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First Study to Evaluate the Capacity of Maraviroc Drug to Protect Against HIV Infection in Samples of Rectal Mucosa From Healthy Volunteers
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Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will assess the potential of MVC as a "on demand" pre-exposure prophylaxis, within a strategy for the prevention of HIV infection in men who have sex with men (MSM).
Drug: Maraviroc
Drug: TVD 300/200 QD
Phase 1
|Study Type:
|Study Design:
|Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:
|PILOT STUDY OF PROTECTION AGAINST ex Vivo HIV INFECTION IN RECTAL MUCOSA IN HEALTHY VOLUNTEERS AFTER ADMINISTRATION OF MARAVIROC
- Infectivity of HIV: p24 production [ Time Frame: Baseline ] [ Designated as safety issue: No ]HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.
- Infectivity of HIV: p24 production [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]HIV replication will be measured by the determination of HIV p24 production in culture supernatant after 12 days of culture. The HIV production in ex vivo cultures from the basal and after drug administration will be compared and the results will be expressed as a measure of Maraviroc efficacy.
- Maraviroc plasmatic levels [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
- Maraviroc levels in rectal mucosa [ Time Frame: Visit 1 (Group 1: day 8, Group 2: day 7, Grop 3: day 9) ] [ Designated as safety issue: No ]
|Estimated Enrollment:
|Study Start Date:
|October 2012
|Estimated Study Completion Date:
|May 2014
|Estimated Primary Completion Date:
|April 2014 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: MVC 300 mg
MVC 300 mg in unique dose
Drug: Maraviroc
Unique dose of Maraviroc 300mg
Active Comparator: TVD 300/200 QD
TVD 300/200 QD during 7 days.
Drug: TVD 300/200 QD
TVD 300/200 QD during 7 days
Detailed Description:
Several clinical trials are currently under way evaluating the safety and effectiveness of ARV-based PrEP for preventing HIV infection. The results of the first efficacy trials of ARV-based PrEP showed fewer HIV infections among study participants receiving the study drugs compared to those receiving placebo. Although the results are promising, concerns about adherence, pharmacokinetics, and toxicity still needs further exploration so new and more effective preventive pharmacological approaches should be evaluated. This trial will evaluate the safety, pharmacokinetics and efficacy of ex vivo HIV infection of rectal mucosa by the CCR5 antagonist drug maraviroc (Selzentry) administered to healthy volunteers. This trial will last approximately one year. Twenty-one volunteers will receive MVC 300 mg orally in a single dose. Study visits will occur at enrollment and at days 0, 7, 9, 14 and 16. All study visits will include a physical examination, blood collection and storage and in the basal visit and a day 7 or 9 the participants will undergo a colonoscopy. Ex vivo HIV infectivity in rectal mucosa biopsies and plasma/mucosa MVC levels will be evaluated.
|Ages Eligible for Study:
|18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:
- Men who have sex with men (MSM)
- Age 18 years or above
- HIV negative at the time of inclusion 4. Signed informed consent
Exclusion Criteria:
- Existence of sexually transmitted infection (STI) or active systemic infection
- Submit a contraindication to rectal biopsy
- Take any drugs concomitantly with interactions with the MVC
- Subject unable to follow protocol
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719627
|Contact: Cecilia Cabrera, MD,PhD
|00 34 93 465 63 74
|Germans Trias i Pujol Hospital
|Badalona, Barcelona, Spain, 08916
|Contact: Cecilia Cabrera, MD,PhD 0034 93 465 65 74 email@example.com
|Principal Investigator: Cecilia Cabrera, MD,PhD
No publications provided
|Responsible Party:
|Fundacio Lluita Contra la SIDA
|ClinicalTrials.gov Identifier:
|NCT01719627 History of Changes
|Other Study ID Numbers:
|Study First Received:
|October 10, 2012
|Last Updated:
|March 18, 2014
|Health Authority:
|Spain: Ministry of Health
Keywords provided by Fundacio Lluita Contra la SIDA:
HIV, Maraviroc, PrEP, Ex vivo infection, rectal mucosa.
Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
ClinicalTrials.gov processed this record on August 28, 2014


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Have you taken our poll, yet?Posted: January 15, 2013 Filed under: Uncategorized Leave a comment
On January 5, 2013, we asked: What topics are you most interested in reading about on this blog? We appreciate all the responses we've received so far.
If you have not yet taken our poll, please do so now by going to our January 5, 2013 post.
Here are the responses so far, as of 10:00 P.M. Eastern Standard Time today.
We'll post a new essay next week.
Have a great day, everyone.
-Nancy, blog editor

subset: commoncrawl


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At the time, he was simply a young starting pitcher who was the lone representative from a struggling franchise that was laying the foundation for what would prove to be the most successful run in professional sports history.
Fourteen years later, the talented right-hander is now being considered one of the most dominant closers this game has seen and serving as the clubhouse leader for a Braves team that is seeking its 12th consecutive division title.
As Smoltz prepares to participate in his sixth All-Star Game on Tuesday night, the Braves right-hander can only sit back and smile about how much things have changed since he allowed Bo Jackson to drive in the go-ahead run in that 1989 Midsummer Classic.
"It's always an honor to go to an All-Star Game," Smoltz said. "My current role has obviously changed into one that is a product of how successful your team is. As a starting pitcher, I had more control over my success. Now, there are so many other variables."
If there has been one definite for the Braves since Smoltz became a full-time closer at the beginning of the 2002 season, it is that they will win almost every game that they possess a lead in the ninth. The record-setting closer, who notched a single-season, National League-record 55 saves last year, is on pace for 59 saves this year, which would better the all-time mark of 57 saves set by Bobby Thigpen in 1990.
Smoltz was forced to begin the evolution from starter to closer after he had Tommy John surgery in 2000. The successful transition has brought thoughts of possible future Hall of Fame consideration. He has 163 wins and with 11 more saves this year will become the first hurler to ever record 100 saves over two consecutive seasons.
"It certainly hasn't been as easy as it might appear," Smoltz said. "There are so many things in this role that I can't control. What's most important to me is helping the team win every game that I pitch."
The Braves, who currently own the best record in the Majors, have won 90 of the past 92 games Smoltz has pitched. He has a 0.95 ERA and has converted 94 percent (89 of 95) save opportunities over the past two years.
"He's about as automatic as automatic gets," Braves manager Bobby Cox said of Smoltz.
Smoltz looks forward to the opportunity to play in this year's All-Star Game that will award the winning league with home-field advantage in the World Series. But he also would like to see the opportunity in the future to sweeten the game's interest with a matchup of International All-Stars against United States All-Stars.
"Whatever the format is, you are going to go out there and give what you can while you're out there," Smoltz said. "Everybody is going out there to win."
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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