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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00109603 |
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 |
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HIV Infections Dyslipidemia Hyperlipidemia Hypercholesterolemia Hypertriglyceridemia |
Drug: Tenofovir disoproxil fumarate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 56 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Diego Antiviral Research Center | |
San Diego, California, United States, 92103 | |
University of Southern California | |
Los Angeles, California, United States, 90033-1079 | |
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 | |
MetroHealth Medical Center | |
Cleveland, Ohio, United States, 44109-1998 | |
Case Western Reserve University | |
Cleveland, Ohio, United States, 44106-5083 | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267-0405 | |
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15213-2582 | |
University of Pennsylvania, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 | |
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 Medical Center |
Study Chair: | Marisa Tungsiripat, MD | The Cleveland Clinic |
Study ID Numbers: | ACTG A5206 |
Study First Received: | April 29, 2005 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00109603 |
Health Authority: | United States: Food and Drug Administration |
Treatment Experienced TDF |
Sexually Transmitted Diseases, Viral Hyperlipidemias Hypertriglyceridemia Metabolic Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases HIV Infections |
Sexually Transmitted Diseases Tenofovir Metabolic disorder Hypercholesterolemia Retroviridae Infections Dyslipidemias Tenofovir disoproxil Lipid Metabolism Disorders |
Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |