Clinical Drug Experience Knowledgebase

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.