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Sponsored by: |
Hospital Clinic of Barcelona |
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Information provided by: | Hospital Clinic of Barcelona |
ClinicalTrials.gov Identifier: | NCT00646984 |
Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.
Design: Pilot, prospective, open, randomized, controlled 3-year study.
Setting and patients: University hospital. Patients with viral load <200 copies/mL and CD4 cell count >450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.
Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA >200 copies/mL while on therapy), immunological failure (CD4 cell count <200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.
Condition | Intervention | Phase |
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HIV-Associated Lipodystrophy Syndrome |
Drug: Standard continuous antiretroviral therapy Drug: CD-4 guided therapy interruption Drug: Viral load driven treatment interruption |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy. |
Enrollment: | 147 |
Study Start Date: | January 2002 |
Study Completion Date: | April 2006 |
Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Standard continuous antiretroviral therapy
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Drug: Standard continuous antiretroviral therapy |
2: Experimental
CD-4 guided interruption arm
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Drug: CD-4 guided therapy interruption
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
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3: Experimental
Viral load driven treatment interruption
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Drug: Viral load driven treatment interruption
Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Hospital Clinic of Barcelona ( Esteban Martinez ) |
Study ID Numbers: | TARV-DEM-LD, AEM 01-0480 |
Study First Received: | March 26, 2008 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00646984 History of Changes |
Health Authority: | Spain: Spanish Agency of Medicines |
Lipodystrophy Treatment interruption HIV |
Sexually Transmitted Diseases, Viral Metabolic Diseases Skin Diseases Acquired Immunodeficiency Syndrome Immunologic Deficiency Syndromes Virus Diseases HIV-Associated Lipodystrophy Syndrome |
HIV Infections Lipodystrophy Sexually Transmitted Diseases Retroviridae Infections Metabolic Disorder Lipid Metabolism Disorders |
Sexually Transmitted Diseases, Viral RNA Virus Infections Metabolic Diseases Disease Immune System Diseases Skin Diseases Immunologic Deficiency Syndromes Virus Diseases HIV-Associated Lipodystrophy Syndrome |
Pathologic Processes Skin Diseases, Metabolic HIV Infections Syndrome Sexually Transmitted Diseases Lipodystrophy Lentivirus Infections Retroviridae Infections Lipid Metabolism Disorders |