Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

Completed

Conditions studied: HIV Infections, Lipodystrophy, Metabolic Diseases, Nutrition Disorders

In brief

Nucleoside reverse transcriptase inhibitors (NRTIs) are a class of anti-HIV (Human Immunodeficiency Virus) drug that can be an important part of an HIV treatment regimen. Because anti-HIV therapy may have negative side effects, there is a great need to carefully study HIV infected patients on such regimens. One negative side effect observed in many HIV infected patients is lipoatrophy, a condition that results in fat loss in the body. It is unclear if NRTIs also have a role in the development of mitochondrial toxicity, a condition that affects the body's ability to produce energy. The purpose of this study is to observe the effects of an NRTI-based, protease inhibitor (PI)-sparing drug regimen on fat loss in HIV infected, treatment-naive adults. Study hypothesis: The initiation of NRTI-containing, PI-sparing therapy will inhibit mitochondrial DNA (mtDNA) synthesis and lead to a decrease in mtDNA content in adipose tissue, skeletal muscle and peripheral blood mononuclear cells (PBMCs), will cause deterioration in mitochondrial function, will increase fat apoptosis and oxidative damage biomarkers, and will lead to progressive decrease in body fat content.

Key facts

Study ID

NCT00119405

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

18

Starts

2005-04-01

Expected to finish

2010-11-01

Last updated by the study team

2017-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1 infected
• Treatment-naive
• Plan to initiate first ARV regimen with 2 NRTIs and an NNRTI
• Plan to include zidovudine as part of first ARV regimen

You may not qualify if…

• Current use of steroids or growth hormone
• Coagulopathies or other bleeding disorders
• Pregnancy or breastfeeding

Where it is running

• University Hospitals of Cleveland — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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