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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HAART-induced Lipodystrophy and Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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r-MetHuLeptin

r-MetHuLeptin SubQ once daily

Group Type ACTIVE_COMPARATOR

r-metHuLeptin

Intervention Type DRUG

Placebo

SubQ once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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r-metHuLeptin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No