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Sponsors and Collaborators: |
University of California, Los Angeles Merck Case Western Reserve University Vanderbilt University Tufts University AltaMed Health Services |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00656175 |
Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease
Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications.
This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.
The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).
Condition | Intervention | Phase |
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HIV Infections Lipodystrophy |
Drug: raltegravir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor Based Antiretroviral Therapy in Women With Fat Accumulation |
Estimated Enrollment: | 40 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Active Comparator
Immediate switch of PI or NNRTI to raltegravir
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Drug: raltegravir
Immediate switch from PI or NNRTI to raltegravir
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Arm B: Active Comparator
Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to raltegravir
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Drug: raltegravir
raltegravir
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory values at screening of
United States, California | |
UCLA CARE Center | |
Los Angeles, California, United States, 90035 | |
Altamed Health Services Corporation | |
Los Angeles, California, United States, 90022 | |
United States, Massachusetts | |
Tufts University School of Medicine | |
Boston, Massachusetts, United States, 02111 | |
United States, Ohio | |
Case School of Medicine | |
Cleveland, Ohio, United States, 44106 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37203 |
Principal Investigator: | Judith S. Currier, M.D. | University of California, Los Angeles |
Study Chair: | Grace McComsey, M.D. | Case School of Medicine |
Responsible Party: | UCLA ( Judith S. Currier, M.D. ) |
Study ID Numbers: | IISP-Raltegravir |
Study First Received: | April 2, 2008 |
Last Updated: | May 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00656175 |
Health Authority: | United States: Institutional Review Board; Canada: Health Canada |
lipodystrophy fat visceral fat HIV women raltegravir |
ART anti HIV therapy NNRTI Protease inhibitor integrase inhibitor treatment experienced |
Virus Diseases Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases HIV Infections Sexually Transmitted Diseases |
Lipodystrophy Acquired Immunodeficiency Syndrome Metabolic disorder Retroviridae Infections Immunologic Deficiency Syndromes Lipid Metabolism Disorders |
RNA Virus Infections Slow Virus Diseases Immune System Diseases |
Skin Diseases, Metabolic Lentivirus Infections Infection |