Botswana TDF/FTC Oral HIV Prophylaxis Trial

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00448669

Run by

Centers for Disease Control and Prevention

People needed

1219

Starts

2007-03-01

Expected to finish

2011-03-01

Last updated by the study team

2020-02-05

Who can join

Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Centers for Disease Control and Prevention — Atlanta, Georgia, United States
• BOTUSA HIV Prevention Research Unit — Gaborone, Botswana

Full record on ClinicalTrials.gov

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