Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborators: AIDS Research Consortium of Atlanta; San Francisco Department of Public Health
• Treatments: Tenofovir

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.