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

Completed · Phase 2 · Has a placebo group

Conditions studied: HAART-induced Lipodystrophy and Metabolic Syndrome

In brief

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.

Key facts

Study ID

NCT00140244

Run by

Beth Israel Deaconess Medical Center

People needed

7

Starts

2001-12-01

Expected to finish

2011-06-01

Last updated by the study team

2017-05-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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