Status:
TERMINATED
Botswana Tenofovir Oral HIV Prophylaxis Trial
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Botswana Ministry of Health
Gilead Sciences
Conditions:
HIV Infection
Eligibility:
All Genders
18-29 years
Phase:
PHASE2
PHASE3
Brief 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...
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 co...
Eligibility Criteria
Inclusion
- citizen of Botswana 18-29 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 effective contraception
- living within 1 hours travel of study clinic
- pass comprehension test
- willing and able to give informed consent
Exclusion
- 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 :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00111150
Start Date
September 1 2005
End Date
March 1 2007
Last Update
March 19 2007
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
Francistown and Gaborone, Botswana