Randomized, Placebo-Controlled Study of Leptin for the Treatment of HIV Lipodystrophy and Metabolic Syndrome
NCT00140244 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2017-05-11
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.
Conditions
- HAART-induced Lipodystrophy and Metabolic Syndrome
Interventions
- DRUG
-
r-metHuLeptin
- DRUG
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH - collaborator INDUSTRY
-
Beth Israel Deaconess Medical Center
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2001-12-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- United States
Study Locations
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