Botswana TDF/FTC Oral HIV Prophylaxis Trial

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study tested whether taking a pill of tenofovir and emtricitabine (two antiretroviral medicines) was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: Botswana Ministry of Health; Gilead Sciences
• Treatments: Emtricitabine; Tenofovir

Criteria

Inclusion Criteria:

• citizen of Botswana 18-39 years old

• sexually active

• HIV uninfected

• Hepatitis B and C uninfected

• Calculated creatinine clearance >= 60 mL/min

• hemoglobin >= 8 gm/dL

• ALT and AST <= 2x ULN

• total bilirubin <= 1.5 mg/dL

• total serum amylase <= 1.5x ULN

• Serum phosphorus >= 2.2 mg/dL

• willing to use hormonal contraception (females)

• living within 1 hours travel of study clinic

• pass comprehension test

• willing and able to give informed consent

Exclusion Criteria:

• 18-20 without parent/guardian consent

• history of significant renal or bone disease

• any chronic illness requiring ongoing prescription medication

• pregnant or breastfeeding

• planning to move away from site in the next year

• participating in another HIV prevention or vaccine safety trial

• any other clinical condition or prior therapy that, in the opinion of the study physician, would make the volunteer unsuitable for the study or unable to comply with the dosing requirements