Observational Study of Fat Loss in HIV Infected Adults Taking Nucleoside Reverse Transcriptase Inhibitors (NRTIs)
Recruitment status was Active, not recruiting
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Purpose
Nucleoside reverse transcriptase inhibitors (NRTIs) are a class of anti-HIV 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.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Role of Mitochondria in the Development of HIV Atrophy |
- Mitochondrial function [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- mtDNA [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- fat apoptosis [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- limb fat [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
- oxidative markers [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
NRTIs are a mainstay of HIV treatment regimens, often part of initial treatment regimens for newly diagnosed patients. Recent data suggest that NRTIs are responsible for lipoatrophy, a condition marked by progressive fat loss. Another negative side effect to antiretroviral (ARV) regimens is mitochondrial toxicity, which can damage the heart, nerves, muscles, kidneys, pancreas and liver, as well as affecting the body's ability to produce energy for important life processes. It has been hypothesized that lipoatrophy may be related to mitochondrial toxicity, but a causal relationship between the two has yet to be established. This study will examine HIV infected treatment-naive patients who are initiating their first ARV regimens. The regimens will contain 2 NRTI, one of which being zidovudine and a non-nucleoside reverse transcriptase inhibitor (NNRTI). The regimens will not contain any PIs.
Patients will participate in this study for 96 weeks. There will be 4 study visits at Weeks 12, 24, 48, and 96. Dual-energy x-ray absorptiometry (DEXA) scans and fat biopsies will occur at all visits. Additionally, blood collection for metabolic testing will occur at Week 12. ARVs will not be provided by this study.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00119405
| United States, Ohio | |
| University Hospitals of Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| Principal Investigator: | Grace A. McComsey, MD | University Hospitals Cleveland Medical Center |
More Information
Additional Information:
| Responsible Party: | Grace McComsey, MD, Case Western Reserve University |
| ClinicalTrials.gov Identifier: | NCT00119405 History of Changes |
| Other Study ID Numbers: | 1R01AI060484-01A2A |
| Study First Received: | July 11, 2005 |
| Last Updated: | February 22, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Lipoatrophy Mitochondria Treatment Naive |
Additional relevant MeSH terms:
|
HIV Infections Metabolic Diseases Lipodystrophy Nutrition Disorders Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Skin Diseases, Metabolic Skin Diseases Lipid Metabolism Disorders Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on September 30, 2016