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Lovastatin: Immunomodulatory Value Evaluation (LIVE)

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ClinicalTrials.gov Identifier: NCT00721305
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : October 4, 2011
Sponsor:
Collaborators:
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Laboratorio Clínico Congregación Mariana
Laboratorios Laproff S.A.
Humax Pharmaceutical
Information provided by (Responsible Party):
Carlos Julio Montoya Guarin, Universidad de Antioquia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
HIV Seropositivity Drug: Lovastatin Other: placebo Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Antiretroviral Effect of Lovastatin on HIV-1-infected Individuals Without Highly Active Antiretroviral Therapy (HAART): A Phase-II Randomized Clinical Trial (RCT)
Study Start Date : August 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lovastatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
 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
Other Name: statin
Placebo Comparator: 2
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


Outcome Measures
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Primary Outcome Measures :
  1. 1. HIV-1 viral load measured as RNA copies per ml of peripheral blood 2. CD4 T-cell count measured as cells per ul of peripheral blood [ Time Frame: Before, 6 and twelve months after the intervention ]

Secondary Outcome Measures :
  1. CD8+ T cell count, CD4/CD8 ratio, Expression of CD38 and HLA-DR, Total serum cholesterol, Cellular cholesterol, Activity of LFA-1 and ICAM-1, Activity of Rho GTPases, Monthly frequency of AIDS defining diseases, hospitalization and mortality [ Time Frame: Before, 6 and twelve months after the intervention ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asymptomatic HIV-1 seropositive individuals, with age ≥ 18 years, who are HAART naive

  • HIV-1 infection confirmed by:

    • positive Western-blot test dated at least six months before admission to the study;
    • a Western-blot test within the last six months, which was also positive for the p31 and p66 bands
  • Detectable viral load < 100,000 copies/ml
  • CD4+ T cell count ≥ 350 cells/ul

Exclusion Criteria:

  • Inability or unwillingness of patients to give written informed consent.
  • Main residence outside Medellin and its metropolitan area, or any indication of difficulties in the follow-up period
  • Participation in other clinical trials
  • Evidence that the patient will exhibit low adherence to intervention and follow-up (Morisky-Green test)
  • Pregnancy or breastfeeding
  • Any type of antiretroviral treatment before admission to the study, and therapy with lipid-lowering drugs during the last six months
  • Antecedents of allergy, contraindications or intolerance to statins
  • Patients receiving medications which can generate relevant interactions with lovastatin: clarithromycin, erythromycin, azithromycin, itraconazole, ketoconazole, nefodozone, cimetidine, rifampin, phenobarbital, carbamazepine, phenytoin.
  • Unwillingness to avoid the consumption of Citrus paradise (grapefruit juice) or Saint John's Wort (Hypericum)
  • Opportunistic infections or any type of AIDS-defining disease
  • Chronic active hepatitis (B or C)
  • Any hepatocellular disease, indicated by elevation of liver enzymes (AST or ALT) more than twice the reference value
  • Renal failure, indicated by serum creatinine ≥ 2 mg/dl
  • Myopathy, indicated by an elevation of creatine phosphokinase (CPK) more than five times the reference values
  • Infection or acute disease that requires in-patient treatment
  • Active substance-related disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721305


Locations
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Colombia
Group of Immunovirology, Research Universitary Center, University of Antioquia
Medellin, Antioquia, Colombia
Sponsors and Collaborators
Universidad de Antioquia
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
Laboratorio Clínico Congregación Mariana
Laboratorios Laproff S.A.
Humax Pharmaceutical
Investigators
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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
More Information
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Publications:
UNAIDS and WHO. AIDS epidemic update 2004. Geneva, Switzerland: Joint United Nations Programme on HIV/AIDS (UNAIDS) and World Health Organization (WHO); 2004 December 2004
Instituto Nacional de Salud. Programa Nacional de Prevención y control ITS/SIDA. Colombia 1983-2002. Bogotá: Instituto Nacional de Salud, Ministerio de Salud de la República de Colombia; 2003

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carlos Julio Montoya Guarin, Associated Professor, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT00721305    
Other Study ID Numbers: COLCIENCIAS 111540820508
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: October 4, 2011
Last Verified: September 2011
Keywords provided by Carlos Julio Montoya Guarin, Universidad de Antioquia:
Type 1 human immunodeficiency virus infection
Lovastatin
Adaptive Immunity
 Cellular cholesterol
Rho GTPases
Lymphocyte function-associated antigen-1
Additional relevant MeSH terms:
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HIV Seropositivity
HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
 Immune System Diseases
Lovastatin
L 647318
Dihydromevinolin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors