Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: tenofovir disoproxil fumarate; placebo
Intervention description: study product taken daily; study product taken daily
Intervention MeSH terms: Tenofovir
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 400.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

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

Eligibility 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.