A Randomized, Controlled, Cross-Over Trial of Safety of Vaginal Use of Carraguard by HIV-Infected Women
|ClinicalTrials.gov Identifier: NCT00213044|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : August 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Carraguard (PC-515)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Actual Study Start Date :||March 2003|
|Study Completion Date :||June 2004|
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|