Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy

Completed · Not applicable

Conditions studied: HIV Infections, Dyslipidemia, Hyperlipidemia, Hypercholesterolemia, Hypertriglyceridemia

In brief

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.

Key facts

Study ID

NCT00109603

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

17

Starts

2005-05-01

Expected to finish

2007-11-01

Last updated by the study team

2012-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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