At a glance
ClinicalIndex Comparison Record- ✓HIV-1 infection confirmed
- ✓Antiretroviral treatment-naive
- ✓Planning to initiate first ARV regimen with 2 NRTIs and an NNRTI
- ✓Zidovudine must be included in first ARV regimen
- ✕Current use of systemic steroids or growth hormone
- ✕Coagulopathies or other bleeding disorders
- ✕Pregnancy or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Role of Mitochondria in the Development of HIV Atrophy
In Brief
An observational study for HIV Infections and 3 related conditions. Completed, enrolled 18 participants across 1 site.
Detailed Summary
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.