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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00122512
Recruitment Status : Terminated
First Posted : July 22, 2005
Last Update Posted : February 10, 2006
Sponsor:
Information provided by:
FHI 360

Tracking Information
First Submitted Date  ICMJE July 19, 2005
First Posted Date  ICMJE July 22, 2005
Last Update Posted Date February 10, 2006
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2005)
To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV
Official Title  ICMJE Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV - An Extended Safety Evaluation
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 evaluate the preliminary effectiveness of TDF 300 mg as an HIV prevention method when taken once a day.
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'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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE HIV Infections
Intervention  ICMJE Drug: Tenofovir Disoproxil Fumarate
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE
 (submitted: July 21, 2005)
500
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malawi
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00122512
Other Study ID Numbers  ICMJE 9876
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE FHI 360
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Irving Hoffman, PA, MPH UNC Center for Infectious Diseases
PRS Account FHI 360
Verification Date February 2006

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