Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy
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Purpose
The purpose of this study is to determine the effect of the anti-HIV drug tenofovir disoproxil fumarate (TDF) on lipid levels in HIV infected adults on stable anti-HIV drug therapy.
Study hypothesis: The addition of TDF to stable background antiretroviral therapy in HIV infected individuals with dyslipidemia will result in a reduction of non-HDL after 12 weeks of treatment.
| Condition | Intervention |
|---|---|
|
HIV Infections Dyslipidemia Hyperlipidemia Hypercholesterolemia Hypertriglyceridemia |
Drug: Tenofovir disoproxil fumarate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Pilot Study to Determine the Impact on Dyslipidemia of the Addition of Tenofovir to Stable Background Antiretroviral Therapy in HIV-Infected Subjects |
- Fasting non-HDL cholesterol at baseline and Weeks 12, 16, and 28
- Fasting HDL, total cholesterol, and triglycerides
- direct LDL by ultracentrifugation
- viral load, CD4 count, and other clinical and laboratory measures
| Enrollment: | 17 |
| Study Start Date: | May 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Use of highly active antiretroviral therapy (HAART) has resulted in significant reductions in morbidity and mortality among HIV infected people. However, significant adverse effects, including dyslipidemia, have been associated with HAART. Dyslipidemia may cause elevations in serum total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglyceride concentrations, as well as a decrease in high-density lipoprotein (HDL) concentrations. Dyslipidemia is of particular concern for patients receiving HAART because the condition is associated with increased risk for cardiovascular events. TDF is an antiretroviral that has exhibited favorable lipid effects in several studies in HIV infected people, but the mechanism for the observed lipid-lowering effect of TDF is unknown. This study will evaluate the efficacy of TDF on lowering non-HDL in HIV infected adults currently on stable HAART. HAART itself will not be provided by this study.
This study will last 32 weeks. Participants will be randomly assigned to one of two study arms. Arm A participants will receive 12 weeks of TDF daily, 4 weeks of no TDF, 12 weeks of placebo daily, then 4 weeks of no TDF. Arm B participants will receive 12 weeks of placebo daily, 4 weeks of no TDF, 12 weeks of TDF daily, then 4 weeks of no TDF. Participants will continue to take their currently prescribed stable HAART regimen for the duration of the study. There will be 13 study visits over the 32 weeks of the study. Clinical assessments will occur at all visits; blood and urine collection will occur at most visits.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected
- HIV viral load less than 400 copies/ml within 28 days prior to study entry
- Treatment with stable HAART for at least 90 days prior to study entry. Patients who have taken TDF, didanosine, unboosted atazanavir, or adefovir within 90 days prior to study entry are not eligible.
- Fasting triglycerides of 150 mg/dl or greater AND less than 1000 mg/dl within 28 days prior to study entry or fasting non-HDL cholesterol 100 mg/dl or greater AND less than 250 mg/dl within 28 days prior to study
- Hepatitis B virus surface antigen negative within 6 months prior to study entry
- Have adhered to a lipid-lowering diet and exercise program for at least 28 days prior to study screening, and willing to continue both for the duration of the study
- Willing to continue any current use of hormone replacement therapy or oral contraceptives for the duration of the study. Participants must have been on a stable dose of these medications for at least 28 days prior to study entry to be eligible.
- Willing to use acceptable means of contraception
Exclusion Criteria:
- Any lipid-lowering agents within 28 days prior to study entry
- Nephrotoxins, such as foscarnet and amphotericin B, within 28 days prior to study entry
- Systemic cancer chemotherapy within 60 days prior to study entry
- Hormonal anabolic therapies or systemic steroids within 6 months prior to study entry
- Allergy or sensitivity to the study drug or its formulation
- Uncontrolled diabetes, as defined by the protocol, within 28 days prior to study entry
- Current hypothyroidism which has been treated for less than 28 days prior to study entry
- History of coronary heart disease, known atherosclerotic disease, cerebrovascular disease, peripheral vascular disease, abdominal aortic aneurysm, or arterial blockage
- Any acute illness within 28 days prior to study entry that, in the opinion of the investigator, may interfere with the study
- Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
Contacts and Locations| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-1079 | |
| University of California, San Diego Antiviral Research Center | |
| San Diego, California, United States, 92103 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center, Denver | |
| Denver, Colorado, United States, 80262-3706 | |
| United States, Florida | |
| University of Miami | |
| Miami, Florida, United States, 33136-1013 | |
| United States, Indiana | |
| Indiana University Hospital | |
| Indianapolis, Indiana, United States, 46202-5250 | |
| Methodist Hospital of Indiana | |
| Indianapolis, Indiana, United States, 46202-5250 | |
| Wishard Hospital | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| University of Maryland, Institute of Human Virology | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287-8106 | |
| United States, Missouri | |
| Washington University (St. Louis) | |
| St. Louis, Missouri, United States, 63108-2138 | |
| United States, New York | |
| NYU/Bellevue | |
| New York, New York, United States, 10016-6481 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267-0405 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109-1998 | |
| Case Western Reserve University | |
| Cleveland, Ohio, United States, 44106-5083 | |
| United States, Pennsylvania | |
| University of Pennsylvania, Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213-2582 | |
| United States, Texas | |
| University of Texas, Galveston | |
| Galveston, Texas, United States, 77555-0435 | |
| Puerto Rico | |
| University of Puerto Rico | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Judith Aberg, MD | New York University School of Medicine |
| Study Chair: | Marisa Tungsiripat, MD | The Cleveland Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00109603 History of Changes |
| Other Study ID Numbers: | ACTG A5206 |
| Study First Received: | April 29, 2005 |
| Last Updated: | October 26, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Treatment Experienced TDF |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Hypercholesterolemia Hyperlipidemias Hypertriglyceridemia Dyslipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Lipid Metabolism Disorders Metabolic Diseases Tenofovir Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on March 03, 2013
