Phase I Safety and Acceptability Study of the Vaginal Microbicide 6% Cellulose Sulfate Gel Among HIV-Infected Women
What is HPTN 049?
HPTN 049 is a multi-site, phase I, double blind, randomized, controlled frequency escalation study of 6% CS gel to be conducted among up to 96 sexually abstinent, and sexually active HIV- infected women from Birmingham, AL; New York, NY; Philadelphia, PA; and Providence, RI. Sexually active participants’ male partners also are included in the study.
There is 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 is a promising candidate microbicide. This HPTN study will complement other prior and ongoing studies of CS gel, in that it will assess the safety and acceptability of CS gel among HIV- infected women. Participants’ male sexual partners (when relevant) also will be asked to assess the acceptability of the gel. As such, this study represents an important contribution to the clinical development of CS gel, thereby accelerating progress toward an eventual efficacy trial of this product.
Female study participants complete once or twice daily intravaginal application of 6% CS gel or control gel for 14 consecutive days between menses. The control arms serve to provide information regarding signs, symptoms and/or morbidity that may be attributed to normal variation and/or the study procedures (e.g., speculum insertion) or use of applicator rather than the investigational product studied. This study will 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; and the systemic toxicity of once and twice daily intravaginal application of 6% cellulose sulfate gel among HIV- infected women.
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 Regimen: 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.
HPTN 049 Publication
El-Sadr WM, Mayer KH, Maslankowski L, Hoesley C, Justman J, Gai F, Mauck C, Absalon J, Morrow K, Masse B, Soto-Torres L, Kwiecien A and the HPTN 049 Team. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS. 2006, 20: 1109-16 PMID: 16691061