Overview

Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV

Status:
Completed
Trial end date:
2006-03-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
FHI 360
Treatments:
Tenofovir
Criteria
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)