NCT00111150

Botswana Tenofovir Oral HIV Prophylaxis Trial

Study of the Safety and Efficacy of Daily Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 1,200 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years – 29 Years
• Healthy volunteers: Accepted

Summary

This study will test whether taking a pill of tenofovir (an antiretroviral medicine) is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection.

Detailed description

Twelve hundred healthy, sexually active women and men, 18-29 years old, without HIV infection will be enrolled in Francistown and Gaborone, Botswana. They will be provided with free male and female condoms, repeated individualized risk-reduction counseling, diagnosis and treatment of sexually transmitted diseases, and women will be provided with a choice of effective family planning methods. In addition, volunteers will be randomized to receive either Tenofovir or a placebo pill to take once a day. Volunteers will be seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status. Persons who become HIV infected during the trial will receive ongoing supportive counseling, CD4 and viral load monitoring, education about HIV infection/disease, and access to HIV care including free antiretrovirals when clinically indicated. Volunteer safety will be monitored by a local ethics committee, Centers for Disease Control Institutional Review Board (CDC IRB) and an independent data safety and monitoring board.

Conditions

• HIV Infection

Interventions

Type	Name	Description
DRUG	Tenofovir Disoproxil Fumarate 300 mg daily

Timeline

• Start date: 2005-09-01
• Completion: 2007-03-01
• First posted: 2005-05-18
• Last updated: 2007-03-19

Locations

2 sites across 2 countries: United States, Botswana