CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Metformin +1 moredrug
Likely dose
Metformin 500mgfrom 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/NCT01612858
NCT01612858Phase 4Completed
CompareCT.gov

Metabolic Abnormalities in HIV-infected Persons

Tufts Medical Center·interventional·Posted Jun 6, 2012·Updated Jun 20, 2016

In Brief

A Phase 4 clinical trial evaluating Metformin and Pioglitazone for Lipodystrophy and HIV Infection. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study measures insulin sensitivity, abdominal fat, and intramuscular fat in HIV-infected persons and examines the effect of an anti-diabetic drug (metformin or pioglitazone) on insulin sensitivity and body fat in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLipodystrophy, HIV Infection
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 6, 2012
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.1 years ago

Interventions

Metformindrug

Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.

Pioglitazonedrug

Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.