Cellulose Sulfate and HIV Transmission Among Women
|ClinicalTrials.gov Identifier: NCT00153777|
Recruitment Status : Terminated (IDMC recommendation)
First Posted : September 12, 2005
Last Update Posted : August 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV Infection||Drug: Cellulose Sulfate gel (6%)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1428 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of 6% Cellulose Sulfate Gel and the Effect on Vaginal HIV Transmission|
|Study Start Date :||July 2005|
|Actual Study Completion Date :||March 2007|
- Combined incidence of HIV-1 and HIV-2 in the study. [ Time Frame: 1 year ]
- Time-to-first incidental gonococcal or chlamydial infection. [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00153777
|Karnataka Health Promotion Trust|
|Medical Research Council|
|Durban, South Africa|
|Makarere University - Mulago Hospital|
|Principal Investigator:||Lut Van Damme, MD, MSc, PhD||CONRAD|