Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV

PHASE2CompletedINTERVENTIONAL
Enrollment

889

Participants

Timeline

Start Date

May 31, 2007

Primary Completion Date

December 31, 2009

Study Completion Date

March 31, 2010

Conditions
HIV Infections
Interventions
DRUG

Tenofovir gel

Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, 1% tenofovir gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.

DRUG

Placebo (Universal HEC placebo)

Participants will be provided with a supply of single-use, pre-filled applicators according to their randomisation. While in the study, participants will be asked to apply a first dose of the assigned study product, placebo gel, within 12 hours prior to coitus and insert a second dose as soon as possible within 12 hours after coitus. They will be advised to use only two doses of gel in a 24-hour period.

Trial Locations (2)

4001

CAPRISA eThekwini Clinical Research Site, Durban

4013

CAPRISA, Vulindlela Clinical Research Site, Pietermaritzburg

All Listed Sponsors
collaborator

FHI 360

OTHER

collaborator

United States Agency for International Development (USAID)

FED

collaborator

CONRAD

OTHER

lead

Centre for the AIDS Programme of Research in South Africa

NETWORK

NCT00441298 - Safety and Effectiveness Study of a Candidate Vaginal Microbicide for Prevention of HIV | Biotech Hunter | Biotech Hunter