Status:
COMPLETED
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Lead Sponsor:
FHI 360
Conditions:
HIV Infections
Eligibility:
FEMALE
18-35 years
Phase:
PHASE2
Brief Summary
This Phase 2 study involving tenofovir disoproxil fumarate (TDF) will assess the extended safety of TDF 300 mg per day among young women who are not HIV-infected.
Detailed Description
The protocol describes a randomized, fully-masked, parallel, placebo-controlled study of TDF for pre-exposure prophylaxis of HIV in high-risk women. TDF was selected for investigation as prophylaxis a...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- HIV seronegative
- Willing and able to give informed consent
- 18 years to 35 years old, inclusive
- Sexually active (on average, coitus 3 times per week)
- Have had more than three sexual partners in the last month
- Willing to use study product as directed
- Willing to adhere to follow-up schedule
- Willing to participate in the study for up to 12 months
- Not pregnant, breast feeding, or desiring a pregnancy during the 12 months of participation
- Have adequate renal function (serum creatinine \< 1.5 mg/dL)
- Have adequate liver function (hepatic transaminases \[ALT and AST\] \< 43 U/L)
- Have adequate serum phosphorus (greater than or equal to 2.2 mg/dL)
- In general good health (no active, serious infections that require parenteral antibiotics; no active clinically significant medical conditions, including heart disease, diabetes, asthma, alcoholism, and cancer)
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00122486
Start Date
July 1 2004
End Date
March 1 2006
Last Update
August 1 2006
Active Locations (3)
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1
Care and Health Program
Douala, Cameroon
2
Virtual Access
Tema, Ghana
3
University of College Hospital
Ibadan, Nigeria