Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy
NCT ID: NCT00109603
Last Updated: 2012-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
17 participants
INTERVENTIONAL
2005-05-31
2007-11-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Tenofovir disoproxil fumarate
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Judith Aberg, MD
Role: STUDY_CHAIR
NYU Langone Health
Marisa Tungsiripat, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Locations
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University of Southern California
Los Angeles, California, United States
University of California, San Diego Antiviral Research Center
San Diego, California, United States
University of Colorado Health Sciences Center, Denver
Denver, Colorado, United States
University of Miami
Miami, Florida, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
Wishard Hospital
Indianapolis, Indiana, United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Washington University (St. Louis)
St Louis, Missouri, United States
Beth Israel Medical Center
New York, New York, United States
NYU/Bellevue
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Case Western Reserve University
Cleveland, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas, Galveston
Galveston, Texas, United States
University of Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Dube MP, Stein JH, Aberg JA, Fichtenbaum CJ, Gerber JG, Tashima KT, Henry WK, Currier JS, Sprecher D, Glesby MJ; Adult AIDS Clinical Trials Group Cardiovascular Subcommittee; HIV Medical Association of the Infectious Disease Society of America. Guidelines for the evaluation and management of dyslipidemia in human immunodeficiency virus (HIV)-infected adults receiving antiretroviral therapy: recommendations of the HIV Medical Association of the Infectious Disease Society of America and the Adult AIDS Clinical Trials Group. Clin Infect Dis. 2003 Sep 1;37(5):613-27. doi: 10.1086/378131. Epub 2003 Aug 15. No abstract available.
Grinspoon S, Carr A. Cardiovascular risk and body-fat abnormalities in HIV-infected adults. N Engl J Med. 2005 Jan 6;352(1):48-62. doi: 10.1056/NEJMra041811. No abstract available.
Martinez E, Tuset M, Milinkovic A, Miro JM, Gatell JM. Management of dyslipidaemia in HIV-infected patients receiving antiretroviral therapy. Antivir Ther. 2004 Oct;9(5):649-63.
Mehta N, Reilly M. Atherosclerotic cardiovascular disease risk in the HAART-treated HIV-1 population. HIV Clin Trials. 2005 Jan-Feb;6(1):5-24. doi: 10.1310/HT0W-NX2N-U2BM-7LUU.
Stein JH. Managing cardiovascular risk in patients with HIV infection. J Acquir Immune Defic Syndr. 2005 Feb 1;38(2):115-23. doi: 10.1097/01.qai.0000147525.26746.07.
Tungsiripat M, Kitch D, Glesby MJ, Gupta SK, Mellors JW, Moran L, Jones L, Alston-Smith B, Rooney JF, Aberg JA. A pilot study to determine the impact on dyslipidemia of adding tenofovir to stable background antiretroviral therapy: ACTG 5206. AIDS. 2010 Jul 17;24(11):1781-4. doi: 10.1097/QAD.0b013e32833ad8b4.
Other Identifiers
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ACTG A5206
Identifier Type: -
Identifier Source: org_study_id