A PILOT STUDY TO DETERMINE THE IMPACT ON DYSLIPIDEMIA OF THE ADDITION OF TENOFOV

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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. A5206 is a double-blind, randomized, placebo-controlled, crossover pilot study to determine the efficacy in respect to lipid-lowering effects of the addition of tenofovir (TDF) to a stable highly active antiretroviral therapy (HAART) regimen in HIV-infected subjects with dyslipidemia. The goal of the study is to assess whether there is evidence of a benefit for TDF, which would then be used to justify a larger study. The study will include 56 subjects with dyslipidemia (having both triglycerides 200 mg/dL and non HDL cholesterol 160 mg/dL), who are virologically suppressed (viral load 400 copies/mL) on stable HAART for 90 days prior to study entry, and who do not plan to change their HAART regimen for the 32 weeks of the study. Subjects will be on treatment (randomized between TDF or placebo for TDF) for 12 weeks, followed by a 4-week washout period, followed by 12 weeks on the other treatment (placebo for TDF or TDF, respectively). There will be fasting lipid panels prior to the start of each treatment period and every 4 weeks throughout each treatment period. Subjects will have 14 study visits and undergo physical exams and additional laboratory testing.