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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

This Phase 2a study involving Tenofovir Disoproxil Fumarate (TDF) will provide extended safety data for high-risk men. Secondarily, the study will assess the feasibility of conducting the trial and evaluate the preliminary effectiveness of TDF 300 mg as an HIV prevention method when taken once a day.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Treatments: Tenofovir

Criteria

• Be willing and able to give informed consent

• Be 18 years or older

• Be willing to use study product as directed

• Be willing to adhere to follow-up schedule

• Be willing to participate in the study for up to 12 months

• Be 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)

• Meet at least one of these three high risk criteria: *Sex with sex worker/bar girl in last 3 months;

• Sex with 2 or more women in last 3 months;

• Sexually transmitted disease (STD) in last 3 months

• Have absence of HIV antibodies by rapid test (at screening and enrollment visit)

• Have absence of hepatitis B (HB) surface antigen (sAg)

• Have adequate renal function (serum creatinine <1.5 mg/dL)

• Have adequate liver function (hepatic transaminases (ALT <54 U/L and AST<46 U/L)

• Have adequate serum phosphorus (>2.2 mg/dL)

• Not be intending to relocate out of the area for the duration of the study participation and does not have a job or other obligations that may require long absences from the area

• Not be receiving an experimental HIV vaccine