ACTG A5206: IMPACT ON DYSLIPIDEMIA OF ADDING TENOFOVIR TO ARV THERAPY IN HIV

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This placebo-controlled crossover study will examine the efficacy of adding tenofovir disoproxil fumarate (TDF) versus placebo to a stable antiretroviral regimen in individuals who have elevated non-HDL cholesterol and triglycerides. TDF is a nucleotide analogue and prodrug of tenofovir and has intrinsic antilipidemic effects. Previous studies wherein TDF replaced other nucleosides resulted in decreased lipid values. This did not allow for differentiating the effects of TDF vs the effects of removing other drugs. This study will circumvent this problem by adding TDF to a stable regimen. The use of a crossover study will eliminate the effects of other variables (e.g., diet, exercise), which may confound the interpretation. The study design will help clear up the actual role of TDF. Patients in a given arm will receive TDF or placebo for 12 weeks, have a 4-week washout, and cross over to the alternate treatment. The primary endpoint is fasting non-HDL cholesterol at baseline, weeks 12, 16, and 28. Secondary endpoints will evaluate the antiviral effect of TDF as well as markers of the potential renal toxicity of TDF. Finding intrinsic antilipidemic effects of TDF may alter recommendations for first-line therapy when dealing with an individual that has pre-existing risk factors for hyperlipidemia and heart disease. This study is AIDS-related.