| Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men |
| Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men |
The purpose of this study is to examine safety and tolerability of daily tenofovir use in HIV-uninfected men. |
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. |
| Phase II |
| Interventional |
| Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study |
| Clinical and behavioral safety |
Number of HIV infections
Genetic characteristics of HIV-1 breakthrough viruses
Participants' adherence with daily TDF |
| HIV Infection |
| Drug: Daily oral tenofovir |
|
|
|
| Active, not recruiting |
| 400 |
| February 2005 |
|
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.
|
| Male |
| 18 Years to 60 Years |
| Yes |
|
| United States |
|
| NCT00131677 |
| CDC-NCHSTP-4323 |
|
| Centers for Disease Control and Prevention |
San Francisco Department of Public Health
AIDS Research Consortium of Atlanta |
| Principal Investigator: |
Kata L Chillag, PhD |
Centers for Disease Control and Prevention |
|
| Principal Investigator: |
Lisa A Grohskopf, MD, MPH |
Centers for Disease Control and Prevention |
|
| Principal Investigator: |
Susan Buchbinder, MD |
San Francisco Dept. of Public Health |
|
| Principal Investigator: |
Melanie Thompson, MD |
AIDS Research Consortium of Atlanta |
|
| Principal Investigator: |
Kenneth H. Mayer, MD |
Fenway Community Health |
|
|
| Centers for Disease Control and Prevention |
| September 2007 |
| August 17, 2005 |
| September 20, 2007 |