To examine safety and tolerability of daily tenofovir use in HIV-uninfected men.

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

Further Study Details: 

Primary Outcomes: Clinical and behavioral safety
Secondary Outcomes: number of HIV infections; genetic characteristics of HIV-1 breakthrough viruses; participants’ adherence with daily TDF
Expected Total Enrollment:  400

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.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Male

Accepts Healthy Volunteers

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 of equal to 2x upper limit of normal (ULN)
• Total bilirubin less than nor 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 egents
• 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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00131677

Lisa A Grohskopf, MD, MPH      404-639-6116    lkg6@cdc.gov
Kata L Chillag, PhD      404-639-0948    kjc7@cdc.gov

California
      San Francisco Department of Pulbic Health, San Francisco,  California,  94102,  United States; Recruiting
Georgia
      AIDS Research Consortium of Atlanta, Atlanta,  Georgia,  30308,  United States; Recruiting

Study chairs or principal investigators

Kata L Chillag, PhD,  Principal Investigator,  Centers for Disease Control and Prevention   
Lisa A Grohskopf, MD, MPH,  Principal Investigator,  Centers for Disease Control and Prevention   
Susan Buchbinder, MD,  Principal Investigator,  San Francisco Dept. of Public Health   
Melanie Thompson, MD,  Principal Investigator,  AIDS Research Consortium of Atlanta   

Study ID Numbers:  CDC-NCHSTP-4323
Last Updated:  August 18, 2005
Record first received:  August 17, 2005
ClinicalTrials.gov Identifier:  NCT00131677
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23