Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome

Phase 2

Completed

• Conditions: HAART-induced Lipodystrophy and Metabolic Syndrome
• Interventions: Drug: Placebo; Drug: r-metHuLeptin

• Registration Number: NCT00140244
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2005-08-30
• Study First Submitted QC: 2005-08-30
• Study First Posted: 2005-09-01
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2015-12-22
• Results First Submitted QC: 2017-02-22
• Status Verified: 2017-04
• Results First Posted: 2017-04-06
• Last Update Submitted: 2017-04-06
• Last Update Posted: 2017-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	SubQ once daily
r-MetHuLeptin	r-metHuLeptin	r-MetHuLeptin SubQ once daily

Primary Outcome Measures

Name	Time	Method
Serum Lipid Levels	At the end of each two month intervention

Secondary Outcome Measures

Name	Time	Method
Viral Load	At the end of each two month intervention
Hepatic Fat Content	At the end of each two month intervention
Insulin Resistance (as Assessed by HOMA-IR)	At the end of each two month intervention
Glycemia (as Assessed by Fasting Glucose)	At the end of each two month intervention
Insulin Levels	At the end of each two month intervention
Interleukin-6 (IL-6) Levels	At the end of each two month intervention
Low Density Lipoprotein (LDL) Cholesterol Levels	At the end of each two month intervention
Free Fatty Acid (FFA) Levels	At the end of each two month intervention
Lean Body Mass	At the end of each two month intervention	lean body mass
Blood Pressure	At the end of each two month intervention	percent change in mean blood pressure
Fibrinogen	At the end of each two month intervention	Fibrinogen
CD4+ Lymphocytes	At the end of each two month intervention

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States