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

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ClinicalTrials.gov Identifier: NCT00122512
Recruitment Status : Terminated
First Posted : July 22, 2005
Last Update Posted : February 10, 2006
Sponsor:
Information provided by:
FHI 360

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir Disoproxil Fumarate Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Phase 2a Study of Tenofovir Disoproxil Fumarate (TDF) for Prevention of HIV – An Extended Safety Evaluation

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the extended safety of TDM 300mg daily among HIV-uninfected men

Secondary Outcome Measures :
  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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00122512


Locations
Malawi
UNC Project, Kamuzu Central Hospital
Lilongwe, Malawi
Sponsors and Collaborators
FHI 360
Investigators
Principal Investigator: Irving Hoffman, PA, MPH UNC Center for Infectious Diseases
More Information
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ClinicalTrials.gov Identifier: NCT00122512     History of Changes
Other Study ID Numbers: 9876
First Posted: July 22, 2005    Key Record Dates
Last Update Posted: February 10, 2006
Last Verified: February 2006

Keywords provided by FHI 360:
AE adverse event
AIDS acquired immunodeficiency syndrome
ALT (SGPT) alanine aminotransferase
ART antiretroviral therapy
AST (SGOT) aspartate aminotransferase
DCF data collection forms
DMC Data Monitoring Committee
FDA (U.S.) Food and Drug Administration
GCP Good Clinical Practice guidelines
HB sAg Hepatitis B surface antigen
ICH International Conference of Harmonisation
IND Investigational New Drug Application
 IRB Institutional Review Board
IU international units
mg milligram(s)
mm3 cubic millimeter(s)
PCR polymerase chain reaction
SAE serious adverse event
TDF tenofovir disoproxil fumarate, GS-4331-05, PMPA prodrug
µg microgram
ULN upper limit of the normal range
WB Western Blot
Human Immunodeficiency Virus
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
 Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents