This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Highly active antiretroviral therapy (HAART) frequently results in body fat redistribution, dyslipidemia, and insulin resistance. Our previous studies in patients with HAART-induced metabolic syndrome showed that: 1) Pioglitazone administration over 12 months alters insulin resistance, blood pressure and lipid profile favorably, 2) R-metHuLeptin replacement at physiologic doses improves insulin resistance in HAART-induced lipoatrophy. The objective of this study is to evaluate whether pioglitazone and/or leptin are effective and safe for the treatment of HAART-induced lipatrophy and whether the combination of leptin and pioglitazone has an additive or multiplicative effect on insulin resistance, hyperlipidemia, body composition and cardiovascular risk factors in HAART-induced lipatrophy. This is a randomized, double-blind, placebo-controlled trial of HIV-infected patients with HAART-induced lipoatrophy.
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