Trial Information

Summary: Treatment for HIV lipodystrophy

Highly active antiretroviral therapy (HAART) induces profound and sustained suppression of human immunodeficiency virus (HIV) replication, and is thus very effective in reducing disease-associated morbidity and mortality in this patient population. However, HAART also results in the development of a lipodystrophic syndrome which is characterized by fat accumulation, fat wasting, or a combination of both, and is associated with components of the metabolic syndrome, including insulin resistance, fasting hypertriglyceridemia, and hypercholesterolemia.

Recent studies have found that seperately leptin and pioglitazone (a diabetes medication) improves both the body changes and metabolic complications of this syndrome. We are now doing this study to look at the combination of these two drugs to see if there will be an additive effect in reversing the metabolic complications in patients with HIV lipodystrophy.

Patient Inclusion Criteria

• Age18 years and above and ability and willingness to give written informed consent
• Documented HIV-1 infection
• At least 6 months of stable cumulative antiretroviral therapy with any available or investigational anti- retroviral medication (protease inhibitor, nucleoside reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor, nucleotide reverse transcriptase inhibitor)
• Lipoatrophy developed after initiating HAART treatment (see criteria below). Leptin levels should be less than 4 ng/ml
• Insulin resistance, impaired fasting glucose, impaired glucose tolerance or type 2 diabetes developed after starting the antiretroviral medications. These categories are defined, respectively, as fasting insulin level above 20 µIU/ml; fasting serum glucose value above 110 mg/dl; 2-hour serum glucose level during a 75 gram oral glucose tolerance test (OGTT) between 140 and 200 mg/dl; and fasting glucose above 126 mg/dl or random glucose level above 200 mg/dl with presence of the classic symptoms of diabetes, such as polyuria, polydipsia, ketonuria, and rapid weight loss (79)
• Hypertriglyceridemia and/or hypercholesterolemia developed after starting the antiretroviral therapy. These categories are defined as fasting triglycerides greater than 150 mg/dl and LDL cholesterol greater than 130 mg/dl, respectively (80)
• Female subjects must have a negative urine pregnancy test before enrollment and must agree to use a barrier contraception i.e. condoms, diaphragm or IUD, with or without a hormonal-based method for the duration of the study. Women who are pregnant or become pregnant during the study and who do not accept some form of contraception will be excluded from the study.

Patient Exclusion Criteria

• History of impaired glucose metabolism or hyperlipidemia prior to antiretroviral use
• Triglyceride levels higher than 1500 mg/dl after the 1 month run-in phase or anytime during the study;
• Abnormal hepatic function: liver function tests higher than twice the upper normal range
• Abnormal renal function: creatinine higher than 1.3 mg/dl
• Any condition/illness that may affect study outcomes such as pregnancy, active infection except HIV, clinically significant malabsorption/malnutrition, malignancy
• Any active hormonal disease and/or hormonal treatment that may affect the outcomes of interest such as clinically overt hypo/hyperthyroidism, hypogonadism, hypercortisolism, or treatment with steroids or growth hormone (exception: patients taking testosterone can be included in the trial if they agree to continue the same dosage for the duration of the trial)
• Present alcoholism or drug abuse. These conditions will be screened for by a detailed history and systems review and baseline laboratory analysis with chemistries, CBC, and hormone levels, and EKG.

For more information,

If you would like to learn more about participating in this study, please send an e-mail message using the form below.