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N/A N=18

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

HIV Infections · Lipodystrophy · Metabolic Diseases · Nutrition Disorders

Enrolled (actual)
18
Serious AEs
11.1%
Results posted
Mar 2017
Primary outcome: Primary: Mitochondrial Function (mtDNA Levels) — 1372 copies per cell

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Primary completion
Nov 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Mitochondrial Function (mtDNA Levels)
1372

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Current use of steroids or growth hormone
  • Coagulopathies or other bleeding disorders
  • Pregnancy or breastfeeding
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00119405). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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