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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Tenofovir

Criteria

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