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Study
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Phase Definitions
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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.
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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
Summary
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
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