23369
document
Efficacy and safety of zidovudine and zalcitabine combined with a combination of herbs in the treatment of HIV-infected Thai patients . A randomized double blind placebo controlled trial to determine the efficacy and safety of combined-herbs ( SH ) given with zidovudine ( ZDV ) and zalcitabine ( ddC ) for the treatment of HIV infection in Thai adults was conducted in 3 hospitals in northern Thailand during 2002 to 2003 . The eligible subjects were HIV-infected Thai adults who had never received anti-retrovirals , had a Karnofski Performance Score ( KPS ) of > or = 70 , and had no opportunistic infections . The subjects were randomized to receive either a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and SH 2.5 g three times per day or a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and placebo 2.5 g three times per day for 24 weeks . The main outcome measures were HIV-RNA , CD4 cells , and blood chemistry profiles prior to the treatment and then every 4 weeks for 24 weeks . The baseline characteristics of 60 evaluable subjects , 40 in the SH group and 20 in the placebo group , were not significantly different . HIV RNA at week 4 and thereafter was significantly decreased from the baseline value in both groups ( p < 0.001 ) . However , the decline in HIV RNA in the SH group was significantly more than that in the placebo group . The CD4 cells in the SH group at week 12 and thereafter were significantly increased from the baseline value . Serious adverse events in the two groups were not observed . It is concluded that an addition of SH herbs to two nucleoside reverse transcriptase inhibitors has greater antiviral activity than antiretrovirals only . The SH herbs may be an alternative for the third anti-retroviral agent in the triple drug regimen for the treatment of HIV infected patients in countries with limited resources .
23370
Intervention_Pharmacological
zidovudine and zalcitabine
23371
Intervention_Control
placebo
23372
Intervention_Pharmacological
zidovudine
23373
Intervention_Pharmacological
zalcitabine
23374
Intervention_Physical
anti-retrovirals
23375
Intervention_Pharmacological
ZDV
23376
Intervention_Pharmacological
ddC
23377
Intervention_Pharmacological
SH
23378
Intervention_Pharmacological
a combination of ZDV 200 mg three times per day , ddC 0.75 mg three times per day , and
23379
Intervention_Control
placebo
23380
Intervention_Pharmacological
SH
23381
Intervention_Control
placebo
23382
Intervention_Pharmacological
SH
23383
Intervention_Pharmacological
SH
23384
Outcome_Other
Efficacy
23385
Outcome_Other
safety
23386
Outcome_Other
efficacy
23387
Outcome_Other
safety
23388
Outcome_Physical
HIV-RNA , CD4 cells , and blood chemistry profiles
23389
Outcome_Physical
HIV RNA
23390
Outcome_Physical
HIV RNA
23391
Outcome_Physical
CD4 cells
23392
Outcome_Adverse-effects
Serious adverse events
23393
Outcome_Physical
antiviral activity
23394
Participant_Condition
HIV-infected Thai patients
23395
Participant_Condition
HIV
23396
Participant_Age
Thai adults
23397
Participant_Condition
HIV-infected
23398
Participant_Age
adults
23399
Participant_Condition
infections
23400
Participant_Sample-size
60 evaluable subjects
23401
Participant_Sample-size
40
23402
Participant_Sample-size
20