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Sponsors and Collaborators: |
Universidad de Antioquia Instituto Colombiano para el Desarrollo de Ciencia y Tecnología COLCIENCIAS Laboratorio Clínico Congregación Mariana Meharry Medical College Laboratorios Laproff S.A. Humax Pharmaceutical |
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Information provided by: | Universidad de Antioquia |
ClinicalTrials.gov Identifier: | NCT00721305 |
The purpose of this study is to determine whether the long-term administration of statins may benefit the clinical and immunological evolution in HIV-1-infected individuals before the use of antiretroviral therapy is required.
Condition | Intervention | Phase |
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HIV Seropositivity |
Drug: Lovastatin Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Antiretroviral Effect of Lovastatin on HIV-1-Infected Individuals Without Highly Active Antiretroviral Therapy (HAART): A Phase-II Randomized Clinical Trial (RCT) |
Estimated Enrollment: | 110 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
In this arm, subjects will receive 40 mg of Lovastatin (2 tablets of 20 mg each, p.o.), in a daily doses, during twelve months
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Drug: Lovastatin
Lovastatin 40 mg daily (2 tablets of 20 mg each, p.o.), during twelve months until the end of the study, or before the end of the study if any AIDS defining disease or toxicity appear
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2: Placebo Comparator
In this arm, subjects will receive placebo (2 tablets which will look externally identical to lovastatin: wrapped in the same way, with the same size, shape and color) |
Other: placebo
Placebo will be administered daily (2 tablets which will look externally identical to intervention: wrapped in the same way, with the same size, shape and color), during twelve months until the end of the study, or before the end of the study if any AIDS defining disease or toxicity appear
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Despite the fact that HAART produces a decrease in HIV-1 replication and plasma HIV-1 RNA levels, and allows an increase in the CD4 T-cell count that leads to a diminution in the incidence of opportunistic infections and mortality, the cost and complexity of HAART regimens, the growing list of long-term side effects, and the eventual development of resistance have underscored the immediate need for additional therapeutic approaches.
Statins exert pleiotropic effects through a variety of mechanisms, among which there are several immunological effects that are related and unrelated to their cholesterol-lowering activity. HIV-1 requires cholesterol and lipid rafts for several key stages of its replication cycle; statins-mediated depletion of cholesterol alters the capacity of a cell to form lipid rafts and decreases the HIV-1 infectivity. On the other hand, statins may exert significant modulator effects in the balance of the cytokine network, and alter the activity of Rho GTPases and LFA-1 and ICAM-1 adhesion molecules. Preliminary studies showed that statins (Lovastatin) had anti HIV-1 activity, and that its administration was safe and efficient to control HIV-1 infection in chronically infected individuals who did not receive HAART (in terms of decreasing viral load and increasing CD4 T-cell count).
Because very limited clinical data are available on this topic, this study will be conducted.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
HIV-1 infection confirmed by:
Exclusion Criteria:
Colombia, Antioquia | |
Group of Immunovirology, Research Universitary Center, University of Antioquia | |
Medellin, Antioquia, Colombia |
Principal Investigator: | Carlos J Montoya, MD, PhD | Universidad de Antioquia |
Study Chair: | Maria T Rugeles, PhD | Universidad de Antioquia |
Study Director: | Fabian A Jaimes, MD, PhD | Universidad de Antioquia |
Responsible Party: | University of Antioquia ( Alberto Uribe ) |
Study ID Numbers: | COLCIENCIAS 111540820508 |
Study First Received: | July 22, 2008 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00721305 History of Changes |
Health Authority: | Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos |
Type 1 human immunodeficiency virus infection Lovastatin Adaptive Immunity |
Cellular cholesterol Rho GTPases Lymphocyte function-associated antigen-1 |
Antimetabolites Sexually Transmitted Diseases, Viral Antilipemic Agents Acquired Immunodeficiency Syndrome Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Immunologic Deficiency Syndromes |
Virus Diseases HIV Seropositivity HIV Infections Sexually Transmitted Diseases Retroviridae Infections Lovastatin |
Antimetabolites RNA Virus Infections Sexually Transmitted Diseases, Viral Molecular Mechanisms of Pharmacological Action Immune System Diseases Antilipemic Agents Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
Immunologic Deficiency Syndromes Virus Diseases HIV Seropositivity HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections Lovastatin |