A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
Randomized, controlled, double-blinded, cross-over trial of 60 HIV-infected women recruited from general medical clinics, family planning clinics, groups/organizations working with persons living with AIDS to assess product safety, effect on genital tract HIV shedding, and product acceptability with vaginal use of Carraguard gel among HIV-infected women. Women had to be abstinent or in a seroconcordant relationship with only one partner for the study period.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized, Controlled, Double-Blind, Cross-Over Trial of Safety, Effect on Genital Tract HIV Shedding, and Acceptability of Vaginal Use of Carraguard by HIV-Infected Women|
- Safety: irritation, effect on vaginal flora, vaginal epithelial disruption determined by visual inspection (Day 7, 14) and colposcopic inspection(Day 7); other adverse effects, which may include UTI or other unforeseen problems (Day 7, 14).
- Genital tract HIV: measured using samples collected by CVL (Day 7, 14) and vaginal swab (Day 7, 14).
- Acceptability: interview-administered questionnaire (Day 7).
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||June 2004|
Carraguard™ (PC-515), the Population Council’s lead candidate microbicide, was tested in a randomized, controlled trial in Chiang Rai, northern Thailand. Safety of daily product use determined by symptoms of irritation, effect on vaginal flora, vaginal epithelial disruption as determined by naked eye inspection (Day 7 and Day 14 of each arm) and colposcopic inspection on (Day 7), and other adverse effects, which may include UTI or other unforeseen problems (Day 7 and Day 14).
Genital tract HIV will be measured using samples collected by CVL (Day 7 and Day 14 of each arm) and vaginal swab (Day 7 and Day 14).
Product acceptability will be assessed through an interview-administered questionnaire once each study arm at the first follow-up visit (Day 7 of each arm), after using the product daily for 7 days.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00213044
|Chiang Rai Health Club|
|Chiang Rai, Thailand, 57001|
|Principal Investigator:||Janneke van de Wijgert, PhD||Population Council|
|Principal Investigator:||Catherine McClean||Centers for Disease Control and Prevention|