Status:
COMPLETED
Botswana TDF/FTC Oral HIV Prophylaxis Trial
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Botswana Ministry of Health
Gilead Sciences
Conditions:
HIV Infections
Eligibility:
All Genders
18-39 years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Twelve hundred and nineteen healthy, sexually active women and men, 18-39 years old, without HIV infection were enrolled in Francistown and Gaborone, Botswana. They were provided with free male and fe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
1219 Patients enrolled
Trial Details
Trial ID
NCT00448669
Start Date
March 1 2007
End Date
March 1 2011
Last Update
February 5 2020
Active Locations (2)
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1
Centers for Disease Control and Prevention
Atlanta, Georgia, United States, 30333
2
BOTUSA HIV Prevention Research Unit
Gaborone, Botswana