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

HIV Infections Clinical Trial

Official title:

Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV – An Extended Safety Evaluation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122512
• Other study ID #: 9876
• Status: Terminated
• Phase: Phase 2
• First received: July 19, 2005
• Last updated: February 9, 2006

Study information

• Verified date: February 2006
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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’s safety profile is comparable to placebo among HIV infected persons, it has striking anti-HIV potency, and it has low potential for selection of resistant viruses. TDF is cleared from the body by the kidneys and is not metabolized by the liver. Therefore, TDF has limited potential to have pharmacokinetic interactions with other hepatically metabolized drugs. Each of these properties is necessary given the realities of the intended target populations. Moreover, initial prevention studies in simian models have provided encouraging results. Finally, the drug’s sponsor is supportive of investigating the potential use of TDF as a preventive, as well as therapeutic agent, will provide TDF for the study, and is willing to make a good faith effort to make TDF available for public health use should it prove to be effective for HIV prevention.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 500
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Tenofovir Disoproxil Fumarate

Locations

Country	Name	City	State
Malawi	UNC Project, Kamuzu Central Hospital	Lilongwe

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men
Secondary	To evaluate the feasibility (i.e. accrual, retention, adherence, change in behavior) of conducting a large scale trial of TDF for HIV prevention in men recruited from a resource-limited setting
Secondary	To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV