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

Status:

TERMINATED

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

Lead Sponsor:

FHI 360

Conditions:

HIV Infections

Eligibility:

MALE

18+ years

Phase:

PHASE2

Brief 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 ev...

Detailed Description

TDF has been selected for investigation as prophylaxis against HIV in high-risk men because of its unique pharmacologic profile. In addition to the convenience of being a once daily single tablet, TDF...

Eligibility Criteria

Inclusion

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

Exclusion

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT00122512

Last Update

February 10 2006

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