Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Role of Mitochondria in the Development of HIV Atrophy
3 other identifiers
observational
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2005
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 11, 2005
CompletedFirst Posted
Study publicly available on registry
July 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedResults Posted
Study results publicly available
March 30, 2017
CompletedMarch 30, 2017
December 1, 2007
5.6 years
July 11, 2005
June 13, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mitochondrial Function (mtDNA Levels)
Mitochondrial gene expression: mtDNA levels are used to quantify this outcome measure.
96 weeks
Eligibility Criteria
HIV positive adults starting their first antiretroviral regimen with either azidothymidine (AZT)-containing combination
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Biospecimen
Fat and Blood for mitochindrial DNA and different nuclear genes that regulate fat and lipid metabolism
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grace McComsey
- Organization
- Case Western Reserve University
Study Officials
- PRINCIPAL INVESTIGATOR
Grace A. McComsey, MD
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2005
First Posted
July 13, 2005
Study Start
April 1, 2005
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
March 30, 2017
Results First Posted
March 30, 2017
Record last verified: 2007-12