Status:
COMPLETED
Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Dyslipidemia
Eligibility:
All Genders
18+ years
Phase:
NA
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:...
Detailed Description
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 dyslipi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00109603
Start Date
May 1 2005
End Date
November 1 2007
Last Update
October 30 2012
Active Locations (20)
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1
University of Southern California
Los Angeles, California, United States, 90033-1079
2
University of California, San Diego Antiviral Research Center
San Diego, California, United States, 92103
3
University of Colorado Health Sciences Center, Denver
Denver, Colorado, United States, 80262-3706
4
University of Miami
Miami, Florida, United States, 33136-1013