The purpose of this study is to examine whether replacing leptin to normal levels can reverse the changes in fat distribution, lipid profile, and other metabolic problems associated with highly active antiretroviral therapy (HAART)-induced lipodystrophy and metabolic syndrome in HIV patients.

Condition	Intervention	Phase
HAART-induced lipodystrophy and metabolic syndrome	Drug: r-metHuLeptin	Phase II

Further Study Details: 

Primary Outcomes: serum lipid levels
Secondary Outcomes: insulin resistance (as assessed by the Boost challenge test and Galvin''''s index); glycemia; apolipoprotein levels and LDL particle size; FFA levels; blood pressure; thrombotic factors; hormone levels; body composition; viral load; lymphocyte subsets; cytokine levels; hepatic and abdominal fat content.
Expected Total Enrollment:  15

Exposure to HIV medications has been associated with metabolic changes including generalized fat depletion (lipoatrophy), high triglyceride levels, and in some patients, high sugar levels or diabetes. This syndrome is associated with a deficiency of leptin, a hormone produced by fat cells. Recent studies involving leptin administration to patients with congenital lipoatrophy have shown dramatic improvements in metabolic parameters such as insulin resistance and hyperlipidemia. Leptin administration to patients with HAART-induced lipoatrophy may also lead to significant improvements in the metabolic abnormalities found in these HIV+ patients. The aims of this study are to examine the effect of leptin administration on insulin resistance and other parameters of the metabolic syndrome in HIV patients with HAART-induced lipoatrophy.

Comparison: Leptin-treated group to placebo-treated group

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• At least 18 years old
• Documented HIV infection
• Exposed to at least 6 months of cumulative highly active antiretroviral medications for HIV
• Developed fat depletion after starting HIV medications
• Low leptin level in the blood
• Fasting triglyceride level > 300 mg/dl

Exclusion Criteria:

• Active infectious diseases, except HIV
• Diabetes prior to starting HIV medications
• Alcohol or drug abuse
• Triglyceride level > 1000 mg/dl
• Significant kidney, liver, or thyroid dysfunction
• Cancer or lymphoma
• Pregnancy or planning to become pregnant during the study

Please refer to this study by ClinicalTrials.gov identifier  NCT00140244

Christos S Mantzoros, MD DSc FACP FACE      (617) 667-8630    cmantzor@bidmc.harvard.edu

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting

Study chairs or principal investigators

Jennifer Lee, MD,  Study Director,  Beth Israel Deaconess Medical Center   

Study ID Numbers:  2001-P-000484
Last Updated:  August 31, 2005
Record first received:  August 30, 2005
ClinicalTrials.gov Identifier:  NCT00140244
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06