HPTN 049
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. |
HPTN 049 paper published!
The HPTN study paper was published in the May 12 2006 issue of the AIDS.
This paper provides the results from the HPTN 049 study, demonstrating that CS vaginal gel is safe, well tolerated and acceptable by HIV-infected women and their male partners. Based on this evidence the protocol team postulates that the development of CS is warranted as a potential method to prevent HIV transmission and acquisition.
Please find the reference for the paper below. Click on the title to view the paper's abstract and to gain access to the full text version on the AIDS website.
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. Safety and acceptability of cellulose sulfate as a vaginal microbicide in HIV-infected women. AIDS. 2006 May 12; 20(8):1109-16.
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.
SDMC Protocol Specialist: Karen Patterson get info
Protocol Co-Chair: Kenneth H. Mayer get info
Protocol Co-Chair: Lisa Maslankowski get info
Protocol Chair: Wafaa El-Sadr get info
| Site |
Target Enrollment |
Cumulative Enrollment |
Implementation Status |
More Info |
|---|---|---|---|---|
|
30309 Birmingham, United States |
20 Female and 8 Male Participants |
15 |
De-Registered |
get more |
|
Bronx-Lebanon Hospital Center Clinical Research Site 30261 Bronx, United States |
n/a; not an enrolling site |
n/a |
De-Registered |
get more |
|
Harlem Prevention Center Clinical Research Site 30276 New York, United States |
20 Female and 8 Male Participants |
15 |
De-Registered |
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|
University of Pennsylvania Health System, HIV Prevention Research Division 30310 Philadelphia, United States |
20 Female and 8 Male Participants |
14 |
De-Registered |
get more |
|
The Miriam Hospital, Department of Immunology, Division of Infectious Disease 2951 Providence, United States |
20 Female and 8 Male Participants |
15 |
De-Registered |
get more |
|
30316 Providence, United States |
n/a; not an enrolling site |
n/a |
Closed to Follow Up |
get more |
