NCT00120770

Cellulose Sulfate (CS) Gel and HIV in Nigeria

Randomized Controlled Trial of Cellulose Sulfate Gel and HIV in Nigeria

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,160 (planned)
• Sponsor: FHI 360 · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Gonorrhea
• Chlamydia Infections

Interventions

Type	Name	Description
DRUG	Cellulose Sulfate Vaginal Gel (Microbicide)

Timeline

• Start date: 2004-11-01
• Completion: 2007-03-01
• First posted: 2005-07-19
• Last updated: 2007-02-28

Locations

2 sites across 1 country: Nigeria