At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
r-metHuLeptin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
- ✓At least 18 years old
- ✓Documented HIV infection
- ✓Exposed to at least 6 months of cumulative HAART (highly active antiretroviral therapy)
- ✓Developed fat depletion (lipoatrophy) after starting HIV medications
Key exclusion· 7
- ✕Active infectious diseases (except HIV)
- ✕Diabetes prior to starting HIV medications
- ✕Alcohol or drug abuse
- ✕Triglyceride level >1000 mg/dL
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Role of Leptin in Highly Active Antiretroviral Therapy (HAART)-Induced Lipodystrophy and Metabolic Syndrome in HAART-Treated HIV Patients
In Brief
A Phase 2 clinical trial evaluating r-metHuLeptin and Placebo for HAART-induced Lipodystrophy and Metabolic Syndrome. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Timeline
Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2001
First PostedSep 2005
Primary CompletionJun 2011
TodayJul 2026
First PostedSep 1, 2005
Enrollment StartDec 1, 2001
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.8 years ago
Interventions
r-metHuLeptindrug
Placebodrug