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)