HIV Infection Clinical Trial
Official title:
Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission
The purpose of the study is to determine the effect of cellulose sulfate on the transmission
of HIV to women via vaginal intercourse. The secondary objectives are the effect on the
transmission of gonorrhea and chlamydia via the same route.
The study hypothesis is that there will be no effect.
Despite the availability of an effective HIV prevention method, i.e. the condom, the
epidemic continues growing. There is thus an urgent need for additional HIV prevention
methods. One of the possibilities is the use of microbicides, i.e. chemical products which
may be used in the vagina or rectum with the potential to prevent HIV infection.
Cellulose sulfate is an HIV entry inhibitor with an in vitro effect on N. gonorrhoeae (NG)
and C. trachomatis (CT) and other sexually transmitted organisms.
The study assess its effect on the vaginal transmission of HIV, NG and CT among women at
high risk of heterosexual STI infection (defined as having had more than two partners in the
last three months and an average of three sexual acts per week).
The study is randomized, triple-blinded, placebo controlled.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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