At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 23 enrolled

Drug / intervention

Leptin +1 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.

Search/NCT00461552

NCT00461552Phase 2Completed

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Therapeutic Approaches to HAART-Induced Lipodystrophy

University of Texas Southwestern Medical Center·interventional·Posted Apr 18, 2007·Updated May 9, 2019

In Brief

A Phase 2 clinical trial evaluating Leptin and Placebo for HIV Infections and Lipodystrophy. Completed, enrolled 23 participants across 1 site.

Detailed Summary

To determine the efficacy and safety of 4 therapeutic interventions on HAART-Induced lipodystrophy. The interventions are: 1) Dietary - the effect of a high carbohydrate vs.a high cis-monounsaturated fatty acid diet. 2) The effect of aerobic exercise with dietary advice. 3) The effect of Omega-3 Fish Oil Capsules. 4) The effect of leptin therapy. These interventions are aimed at improving the metabolic complications of HAART therapy such as elevated lipids, and insulin resistance or diabetes.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHIV Infections, Lipodystrophy

CountriesUnited States

CollaboratorsAmylin Pharmaceuticals, LLC.

Timeline

Phase 2CompletedFinished

2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJan 2003

First PostedApr 2007

Primary CompletionSep 2014

TodayJul 2026

First PostedApr 18, 2007

Enrollment StartJan 1, 2003

Primary CompletionSep 1, 2014

TodayJul 2, 2026

Enrollment to primary: 11.7 yearsPosted 19.2 years ago

Interventions

Leptindrug

weight based, sub-cutaneous injection, twice daily

Placeboother

weight based, sub-cutaneous injection, twice daily