Status:
COMPLETED
Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta
Conditions:
HIV Infection
Eligibility:
MALE
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men.
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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00131677
Start Date
February 1 2005
End Date
August 1 2009
Last Update
March 10 2014
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
San Francisco Department of Public Health
San Francisco, California, United States, 94102
2
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
3
Fenway Community Health
Boston, Massachusetts, United States, 02115