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Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
This study is ongoing, but not recruiting participants.
First Received: August 17, 2005   Last Updated: September 20, 2007   History of Changes
Sponsor: Centers for Disease Control and Prevention
Collaborators: San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Information provided by: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00131677
  Purpose

The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.


Condition Intervention Phase
HIV Infection
Drug: Daily oral tenofovir
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Clinical and behavioral safety

Secondary Outcome Measures:
  • Number of HIV infections
  • Genetic characteristics of HIV-1 breakthrough viruses
  • Participants' adherence with daily TDF

Estimated Enrollment: 400
Study Start Date: February 2005
Detailed Description:

This study will assess the clinical and behavioral safety and tolerability of oral daily TDF use as pre-exposure prophylaxis (PrEP) to prevent HIV infection in uninfected men.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy biologic male (male at birth)
  • 18-60 years of age
  • HIV-1 negative by licensed, commercially available, FDA-approved whole blood rapid enzyme immunoassay (EIA) at screening and enrollment
  • Reports any anal sex with a man in the last 12 months
  • Able to understand and pass comprehension assessment questionnaire
  • Able to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
  • Able to understand English
  • Adequate renal function: calculated creatinine clearance of at least 70 mL/min
  • Hepatic transaminases (AST and ALT) less than or equal to 2x upper limit of normal (ULN)
  • Total bilirubin less than or equal to 1.5 mg/dL
  • Absolute neutrophil count at least 1,500/mm3;
  • Platelets at least 100,000/mm3;
  • Hemoglobin at least 9.5 g/dL
  • Serum amylase less than or equal to 1.5 x ULN
  • Biochemical profile: within normal limits for serum phosphorus, potassium, sodium, and calcium.
  • Hepatitis B surface antigen negative
  • Normal urine dipstick or urinalysis (UA)

Exclusion Criteria:

  • Active untreated syphilis
  • Current uncontrolled hypertension (blood pressure > 160/100 mmHg)
  • Mutually monogamous for > one year with a known HIV antibody negative partner
  • History of chronic renal disease, known osteoporosis, osteomalacia, or osteopenia
  • Current or expected participation in other longitudinal HIV behavioral or biomedical research study
  • Current HIV antiretroviral use
  • Receiving or planning to receive on-going therapy with any nephrotoxic agents or experimental/investigational agents
  • Previous or expected requirements for the administration of immunosuppressive/ immunomodulatory therapy (e.g. chronic systemic steroids, interferon, interleukins, chemotherapy, radiation).
  • Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication.
  • Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
  • Imminently life-threatening medical conditions (malignancy, immunosuppressive disease [e.g. lymphoma]), or other serious disease or conditions (e.g. cardiovascular, renal, diabetes) within the last 5 years or that are unstable and/or require chronic medication that would impede compliance with study requirements and complicate the interpretation of adverse events
  • Expected to be non-compliant with study visits or planning to move within 24 months to an area where the study will not be conducted
  • Any other clinical or social condition, prior therapy, occupation, or other responsibility, that, in the opinion of the investigator, would interfere with, or serve as a contraindication to study participation or compliance with the dosing requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00131677

Locations
United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Massachusetts
Fenway Community Health
Boston,, Massachusetts, United States, 02115
Sponsors and Collaborators
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Investigators
Principal Investigator: Kata L Chillag, PhD Centers for Disease Control and Prevention
Principal Investigator: Lisa A Grohskopf, MD, MPH Centers for Disease Control and Prevention
Principal Investigator: Susan Buchbinder, MD San Francisco Dept. of Public Health
Principal Investigator: Melanie Thompson, MD AIDS Research Consortium of Atlanta
Principal Investigator: Kenneth H. Mayer, MD Fenway Community Health
  More Information

No publications provided

Study ID Numbers: CDC-NCHSTP-4323
Study First Received: August 17, 2005
Last Updated: September 20, 2007
ClinicalTrials.gov Identifier: NCT00131677     History of Changes
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 09, 2009