Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men
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ClinicalTrials.gov Identifier: NCT00131677 |
Recruitment Status :
Completed
First Posted : August 19, 2005
Results First Posted : March 10, 2014
Last Update Posted : March 10, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection | Drug: tenofovir disoproxil fumarate Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Phase II Extended Safety Study of Tenofovir Disoproxil Fumarate (TDF) Among HIV-1 Negative Men |
Study Start Date : | February 2005 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Active Comparator: active immediate
participants in this arm start study product immediately upon enrollment
|
Drug: tenofovir disoproxil fumarate
study product taken daily
Other Name: Viread |
Placebo Comparator: placebo immediate
participants in this arm start study product immediately upon enrollment
|
Drug: placebo
study product taken daily |
Active Comparator: active delayed
persons in this arm start study product 9 months after enrollment
|
Drug: tenofovir disoproxil fumarate
study product taken daily
Other Name: Viread |
Placebo Comparator: placebo delayed
participants in this arm start study product nine months after enrollment
|
Drug: placebo
study product taken daily |
- Clinical Safety--Creatinine Elevations [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]Grade 3 or 4 Creatinine elevations (per National Institutes of Health Division of AIDS toxicity scale)
- Clinical Safety--Hypophosphatemia [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]Grade 3 or 4 hypophosphatemia (per National Institutes of Health Division of AIDS toxicity scale)
- Number of Breakthrough HIV Infections [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]Number of participants with HIV seroconversions occuring while on study drug
- Adherence to Study Drug [ Time Frame: 24 months (immediate arm) and 15 months (delayed arm) ]Estimated exposure to study drug (active and placebo) as assessed by Medication Event Monitoring System (MEMS) caps.
- Behavioral Safety--Unprotected Anal Sex (UAS) [ Time Frame: Nine months ]Change in percent of participants reporting unprotected anal intercourse--baseline vs. months 3 through 9 on study.
- >5% Bone Mineral Density Decline at Femoral Neck [ Time Frame: 24 months (immediate arm), 15 months (delayed arm) ]Percent of San Francisco participants in the TDF vs. placebo groups who were found to have >5% decline in Bone Mineral Density at the femoral neck.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131677
United States, California | |
San Francisco Department of Public Health | |
San Francisco, California, United States, 94102 | |
United States, Georgia | |
AIDS Research Consortium of Atlanta | |
Atlanta, Georgia, United States, 30308 | |
United States, Massachusetts | |
Fenway Community Health | |
Boston,, Massachusetts, United States, 02115 |
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 |
Responsible Party: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00131677 |
Other Study ID Numbers: |
CDC-NCHHSTP-4323 |
First Posted: | August 19, 2005 Key Record Dates |
Results First Posted: | March 10, 2014 |
Last Update Posted: | March 10, 2014 |
Last Verified: | August 2013 |
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Tenofovir Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents |