HPTN 049
Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women
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What was HPTN 049?
A Phase I, double blind, randomized, controlled, frequency escalation study with 14 days of product exposure and follow-up to assess the safety and acceptability of 6% cellulose sulfate (CS) gel for vaginal use versus a control gel among HIV-infected women and to assess the acceptability of CS gel among the HIV-infected male sexual partners of female participants.
Who participated in the study?
Sexually abstinent and sexually active HIV-infected women; HIV infected male partners of sexually active women (up to 80 women and up to 32 men).
What happened during the study?
Participants applied either 6% cellulose sulfate gel or a placebo gel intravaginally once or twice daily for 14 intramenstrual days (see protocol for regimen table).
Results
CS gel was safe with no reported severe or life-threatening adverse events (AE).
Why was this study important?
There was an urgent need to develop a safe and effective vaginal microbicide to prevent heterosexual transmission of HIV. Based on available pre-clinical and clinical data, CS gel was a promising candidate microbicide.
Protocol Status
Concluded
Study Purpose
To assess the safety and acceptability of 6% cellulose sulfate (CS) gel for vaginal use versus a control gel among HIV-infected women; to assess the acceptability of CS gel among the HIV-infected male sexual partners of female participants.
Study Design
Multisite, Phase I, double blind, randomized, controlled, frequency escalation study with 14 days of product exposure and follow-up.
Study Population
Sexually abstinent and sexually active HIV-infected women; HIV infected male partners of sexually active women.
Study Size
Up to 80 women and up to 32 men.
Study Duration
Accrual will require up to 18 months. Each female participant will be followed for 14 days. The entire study should be completed within 19 months.
Treatment Regime
Participants will apply either 6% cellulose sulfate gel or a placebo gel intravaginally once or twice daily for 14 intramenstrual days (see protocol for regimen table).
Primary Objectives
To assess the local toxicity of once and twice daily intravaginal application of 6% CS gel on the vulvar and cervicovaginal mucosa of HIV-infected women versus a control gel.
To assess the systemic toxicity of once and twice daily intravaginal application of 6% CS gel among HIV-infected women.
Secondary Objectives
To assess the acceptability of, and adherence to, a short-term regimen of 6% CS gel among HIV-infected women and their HIV-infected male sexual partners.
Other Objectives
Study Documents
Providence, United States
2951