Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women
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).
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.