Metabolic Abnormalities in HIV-infected Persons
|ClinicalTrials.gov Identifier: NCT01612858|
Recruitment Status : Completed
First Posted : June 6, 2012
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lipodystrophy HIV Infection||Drug: Metformin Drug: Pioglitazone||Phase 4|
Although HIV antiretroviral medications have helped patients live longer, they have also been associated with side effects including insulin resistance and changes in body fat distribution. Changes in body fat distribution associated with HIV antiretroviral medications may result in increased fat in the abdomen, neck, and upper back, which is often called central fat deposition. HIV antiretroviral medications may also result in loss of fat in legs, arms, and face, which is often called peripheral fat atrophy.
This study will obtain preliminary data on the effect of 12 weeks of metformin on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and central fat deposition. Similarly, this study will obtain preliminary data on the effect of 12 weeks of pioglitazone on insulin sensitivity and hepatic and peripheral muscle fat in HIV-infected persons with insulin resistance and peripheral fat atrophy.
This study involves taking a drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for a period of 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metabolic Abnormalities in HIV-infected Persons|
|Study Start Date :||June 2011|
|Primary Completion Date :||November 2014|
|Study Completion Date :||November 2014|
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.
Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
Other Name: Actos
- Change in Insulin Sensitivity From Baseline to Week 12 Post-treatment With Insulin Sensitizing Agent [ Time Frame: 3 months ]Change in insulin sensitivity measured by 2 hour euglycemic-hyperinsulinemic clamp from baseline to week 12 post treatment with metformin or pioglitazone
- Change in Hepatic Fat From Baseline to Week 12 Post-treatment With an Insulin Sensitizing Agent [ Time Frame: 12 weeks ]Change in hepatic fat was measured after 12 weeks of treatment with metformin or pioglitazone using magnetic resonance spectroscopy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01612858
|United States, Massachusetts|
|Tufts Medical Center|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Rakhi Kohli, MD, MS||Tufts Medical Center|