Cellulose Sulfate (CS) Gel and HIV in Nigeria
This is a Phase 3, multi-center, randomized, placebo-controlled trial to determine the effectiveness and safety of the 6% cellulose sulfate (CS) vaginal gel for the prevention of HIV infection.
Drug: Cellulose Sulfate Vaginal Gel (Microbicide)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria|
- Incidence of HIV-1 and HIV-2 infection as determined by detection of HIV antibodies from oral mucosal transudate (OMT) specimens.
- Incidence of genital gonorrhea or chlamydia as determined by DNA probe technology from self-administered vaginal swabs.
|Study Start Date:||November 2004|
|Estimated Study Completion Date:||March 2007|
This is a Phase 3, multi-center, randomized, placebo-controlled trial to assess the effectiveness of CS gel in preventing male-to-female vaginal transmission of HIV among HIV sero-negative women at high risk for HIV infection. Eligible participants who are HIV negative, at risk for becoming infected, and are willing to use a vaginal microbicide each time they have intercourse throughout 12 months of study participation will be recruited in Port Harcourt and Lagos, Nigeria. The enrollment phase will last until 2,160 women have enrolled. It is anticipated that the enrollment will be completed within 12 months.
|Lagos University, College of Medicine, Center 10151|
|University of Port Harcourt Teaching Hospital, Center 10152|
|Port Harcourt, Nigeria|
|Study Director:||Vera Halpern, MD||FHI 360|