Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00122512
First received: July 19, 2005
Last updated: February 9, 2006
Last verified: February 2006

July 19, 2005
February 9, 2006
Not Provided
Not Provided
To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men
To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men.
Complete list of historical versions of study NCT00122512 on ClinicalTrials.gov Archive Site
  • 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
  • To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV
  • 1) 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.
  • 2) To assess the preliminary effectiveness of TDF in preventing HIV infection among men at high risk for HIV.
Not Provided
Not Provided
 
Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV – An Extended Safety Evaluation

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
HIV Infections
Drug: Tenofovir Disoproxil Fumarate
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
500
Not Provided
Not Provided
  • 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
Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Malawi
 
NCT00122512
9876
Not Provided
Not Provided
FHI 360
Not Provided
Principal Investigator: Irving Hoffman, PA, MPH UNC Center for Infectious Diseases
FHI 360
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP