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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00119405 |
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: | Cohort, Prospective |
| Official Title: | Role of Mitochondria in the Development of HIV Atrophy |
Fat and Blood for mitochindrial DNA and different nuclear genes that regulate fat and lipid metabolism
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | March 2009 |
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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
HIV positive adults starting their first antiretroviral regimen with either AZT-containing combination
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| University Hospitals of Cleveland | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Grace A. McComsey, MD 216-844-3645 mccomsey.grace@clevelandactu.org | |
| Contact: Norma Storer, RN 216-8442-752 storer.norma@clevelandactu.org | |
| Principal Investigator: Grace A. McComsey, MD | |
| Principal Investigator: | Grace A. McComsey, MD | University Hospitals of Cleveland |
More Information
| Responsible Party: | Case Western Reserve University ( Grace McComsey, MD ) |
| Study ID Numbers: | 1R01AI060484-01A2A, 1R01-AI060484-01A2A |
| Study First Received: | July 11, 2005 |
| Last Updated: | May 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00119405 History of Changes |
| Health Authority: | United States: Federal Government |
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Lipoatrophy Mitochondria Treatment Naive |
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Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Antiviral Agents Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Anti-Retroviral Agents |
HIV Infections Lipodystrophy Sexually Transmitted Diseases Nutrition Disorders Atrophy Metabolic Disorder Retroviridae Infections Lipid Metabolism Disorders |
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Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lipodystrophy Nutrition Disorders Retroviridae Infections Nucleic Acid Synthesis Inhibitors RNA Virus Infections Metabolic Diseases |
Immune System Diseases Skin Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases HIV Infections Skin Diseases, Metabolic Sexually Transmitted Diseases Lentivirus Infections Lipid Metabolism Disorders |
