Status:
COMPLETED
Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amgen
Conditions:
HAART-induced Lipodystrophy and Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00140244
Start Date
December 1 2001
End Date
June 1 2011
Last Update
May 11 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215