Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy
A Pilot Study to Determine the Impact on Dyslipidemia of the Addition of Tenofovir to Stable Background Antiretroviral Therapy in HIV-Infected Subjects
1 other identifier
interventional
17
2 countries
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable hiv-infections
Started May 2005
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2005
CompletedStudy Start
First participant enrolled
May 1, 2005
CompletedFirst Posted
Study publicly available on registry
May 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedOctober 30, 2012
October 1, 2012
2.2 years
April 29, 2005
October 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fasting non-HDL cholesterol at baseline and Weeks 12, 16, and 28
Secondary Outcomes (3)
Fasting HDL, total cholesterol, and triglycerides
direct LDL by ultracentrifugation
viral load, CD4 count, and other clinical and laboratory measures
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
University of Southern California
Los Angeles, California, 90033-1079, United States
University of California, San Diego Antiviral Research Center
San Diego, California, 92103, United States
University of Colorado Health Sciences Center, Denver
Denver, Colorado, 80262-3706, United States
University of Miami
Miami, Florida, 33136-1013, United States
Indiana University Hospital
Indianapolis, Indiana, 46202-5250, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202-5250, United States
Wishard Hospital
Indianapolis, Indiana, 46202, United States
University of Maryland, Institute of Human Virology
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287-8106, United States
Washington University (St. Louis)
St Louis, Missouri, 63108-2138, United States
Beth Israel Medical Center
New York, New York, 10003, United States
NYU/Bellevue
New York, New York, 10016-6481, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0405, United States
Case Western Reserve University
Cleveland, Ohio, 44106-5083, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109-1998, United States
University of Pennsylvania, Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-2582, United States
University of Texas, Galveston
Galveston, Texas, 77555-0435, United States
University of Puerto Rico
San Juan, 00936-5067, Puerto Rico
Related Publications (6)
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.
PMID: 12942391BACKGROUNDGrinspoon 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.
PMID: 15635112BACKGROUNDMartinez 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.
PMID: 15535403BACKGROUNDMehta 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.
PMID: 15765307BACKGROUNDStein 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.
PMID: 15671795BACKGROUNDTungsiripat 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.
PMID: 20495438RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Judith Aberg, MD
NYU Langone Health
- STUDY CHAIR
Marisa Tungsiripat, MD
The Cleveland Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2005
First Posted
May 2, 2005
Study Start
May 1, 2005
Primary Completion
July 1, 2007
Study Completion
November 1, 2007
Last Updated
October 30, 2012
Record last verified: 2012-10