At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 9 enrolled
Drug / intervention
Leptin +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome: A Randomized, Double-blind, Placebo-controlled Clinical Trial
In Brief
A Phase 2 clinical trial evaluating Leptin, Pioglitazone or metformin, and 1 other intervention for HIV Lipodystrophy. Completed, enrolled 9 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether patients with HIV lipodystrophy (fat wasting) benefit from taking the combination of two drugs, one insulin sensitizer (either metformin or pioglitazone, both diabetes drugs) and leptin (a natural hormone produced by your fat cells). Our hope is that they will improve sugar and fat metabolism and positively affect the body fat changes you have noticed while taking HAART.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Lipodystrophy
CountriesUnited States
CollaboratorsAmerican Diabetes Association
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedAug 2006
Primary CompletionMay 2011
Study CompletionJun 2011
TodayJul 2026
First PostedAug 10, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2011
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 19.9 years ago
Interventions
Leptindrug
Pioglitazone or metformindrug
Placebodrug