Lovastatin: Immunomodulatory Value Evaluation (LIVE)

This study has been completed.

Sponsor:

Collaborators:

Instituto Colombiano para el Desarrollo de Ciencia y Tecnología COLCIENCIAS

Laboratorio Clínico Congregación Mariana

Laboratorios Laproff S.A.

Humax Pharmaceutical

Information provided by (Responsible Party):

Carlos Julio Montoya Guarin, Universidad de Antioquia

ClinicalTrials.gov Identifier:

NCT00721305

First received: July 22, 2008

Last updated: September 30, 2011

Last verified: September 2011

History of Changes

Purpose

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
HIV Seropositivity	Drug: Lovastatin Other: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Statins

Drug Information available for: Lovastatin

U.S. FDA Resources

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]


Enrollment:	112
Study Start Date:	August 2008
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: placebo

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721305

Locations


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 Ciencia y Tecnología COLCIENCIAS

Laboratorio Clínico Congregación Mariana

Laboratorios Laproff S.A.

Humax Pharmaceutical

Investigators


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

Montoya CJ, Higuita EA, Estrada S, Gutierrez FJ, Amariles P, Giraldo NA, Jimenez MM, Velasquez CP, Leon AL, Rugeles MT, Jaimes FA. Randomized clinical trial of lovastatin in HIV-infected, HAART naïve patients (NCT00721305). J Infect. 2012 Dec;65(6):549-58. doi: 10.1016/j.jinf.2012.10.016. Epub 2012 Oct 17.

Montoya CJ, Jaimes F, Higuita EA, Convers-Páez S, Estrada S, Gutierrez F, Amariles P, Giraldo N, Peñaloza C, Rugeles MT. Antiretroviral effect of lovastatin on HIV-1-infected individuals without highly active antiretroviral therapy (The LIVE study): a phase-II randomized clinical trial. Trials. 2009 Jun 18;10:41. doi: 10.1186/1745-6215-10-41.


Responsible Party:	Carlos Julio Montoya Guarin, Associated Professor, Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT00721305 History of Changes
Other Study ID Numbers:	COLCIENCIAS 111540820508
Study First Received:	July 22, 2008
Last Updated:	September 30, 2011
Health Authority:	Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by 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:


HIV Seropositivity HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases	Lovastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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