Metabolic Abnormalities in HIV-infected Persons

Status Active, not recruiting

Clinical Trial Summary

This 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.

Clinical Trial Description

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.

Insulin resistance is a pre-disease condition that often leads to diabetes after 10 to 20 years. Insulin is a hormone made by the body that tells the body to store glucose in muscle and fat. People with insulin resistance often need more insulin to store the same amount of glucose. Both insulin resistance and changes in fat distribution in HIV-infected persons are areas of active research because they are both associated with an increased risk of heart disease.

This study examines the relationship between insulin resistance and changes in body fat distribution in HIV-infected persons. This study will recruit both HIV-infected and uninfected persons. The investigators will compare findings between HIV-infected persons with central fat deposition and HIV-infected persons with peripheral fat atrophy, as well as between HIV-infected and uninfected persons.

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01612858
Study type	Interventional
Source	Tufts Medical Center
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	June 2011
Completion date	April 2015

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02135419` - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions	Phase 3
Active, not recruiting	`NCT02663856` - My Smart Age With HIV: Smartphone Self-assessment of Frailty
Completed	`NCT02663869` - Aging With HIV at Younger vs Older Age: a Diverse Population With Distinct Comorbidity Profiles
Completed	`NCT02921516` - Growing Up: Intervening With HIV-Positive Adolescents in Resource-Poor Settings	N/A
Terminated	`NCT02743598` - Liraglutide for HIV-associated Neurocognitive Disorder	Phase 4
Completed	`NCT02846402` - Impact of HIV Self-testing Among Female Sex Workers in Kampala, Uganda	N/A
Completed	`NCT02659306` - Metformin Immunotherapy in HIV Infection	Phase 1
Completed	`NCT02564341` - Targeting Effective Analgesia in Clinics for HIV - Intervention	N/A
Active, not recruiting	`NCT02302950` - A Retrospective Analysis of Raltegravir Use in Minority HIV Infected Women in Houston, Texas	N/A
Terminated	`NCT02109224` - Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection	Phase 1
Completed	`NCT01830595` - Lactoferrin Treatment in HIV Patients	Phase 2
Completed	`NCT01852942` - Reversing Tissue Fibrosis to Improve Immune Reconstitution in HIV	Phase 2
Terminated	`NCT01902186` - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir	Phase 4
Completed	`NCT02269605` - Bryostatin-1 Effect on HIV-1 Latency and Reservoir in HIV-1 Infected Patients Receiving Antiretroviral Treatment	Phase 1
Completed	`NCT01946217` - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials	N/A
Completed	`NCT02525146` - Birmingham Access to Care Study	N/A
Completed	`NCT02527135` - Text Messaging to Improve HIV Testing Among Young Women in Kenya	N/A
Completed	`NCT02118168` - Observational Study for the Extended Follow-up of the Patients Enrolled in the Therapeutic Clinical Trial ISS T-002	N/A
Active, not recruiting	`NCT02602418` - Neural Correlates of Working Memory Training for HIV Patients	N/A
Completed	`NCT01805427` - Antiretroviral Therapy and Extreme Weight	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.