Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women

PHASE2CompletedINTERVENTIONAL
Enrollment

5,029

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
HIV Infections
Interventions
DRUG

Emtricitabine/tenofovir disoproxil fumarate

200 mg/300 mg tablet

DRUG

Emtricitabine/tenofovir disoproxil fumarate placebo

placebo tablet

DRUG

Tenofovir disoproxil fumarate

300 mg tablet

DRUG

Tenofovir disoproxil fumarate placebo

placebo tablet

DRUG

Tenofovir 1% vaginal gel

1 gm/100 ml of 1% gel

DRUG

Tenofovir placebo

placebo gel

Trial Locations (15)

2001

Wits Reproductive Health and HIV Institute CRS (WRHI CRS), Johannesburg

2571

CAPRISA Aurum CRS, Klerksdorp

3630

Botha's Hill CRS, Westville

Isipingo CRS, Westville

4001

eThekwini CRS, Durban

4030

Chatsworth CRS, Chatsworth

4091

Overport CRS, Asherville

4170

Umkomaas CRS, eMkhomazi

4340

Verulam CRS, Verulam

4400

Tongaat CRS, Tongaat

Unknown

Soweto MTN CRS, Johannesburg

MU-JHU Research Collaboration CRS, Kampala

Seke South CRS, Chitungwiza

Zengeza CRS, Chitungwiza

Spilhaus CRS, Harare

Sponsors
All Listed Sponsors
collaborator

Microbicide Trials Network

NETWORK

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT00705679 - Safety and Effectiveness of TFV 1% Gel, TDF Tablets, and FTC/TDF Tablets in Preventing HIV in Women | Biotech Hunter | Biotech Hunter