Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
112 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-08-31
Study Completion Date
2011-07-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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HIV Seropositivity
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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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
Group Type
EXPERIMENTAL
Lovastatin
Intervention Type
DRUG
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
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)
Group Type
PLACEBO_COMPARATOR
placebo
Intervention Type
OTHER
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
Interventions
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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
Intervention Type
DRUG
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
Intervention Type
OTHER
Other Intervention Names
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statin
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
OTHER_GOV
Sponsor Role
collaborator
Laboratorio Clínico Congregación Mariana
OTHER
Sponsor Role
collaborator
Laboratorios Laproff S.A.
INDUSTRY
Sponsor Role
collaborator
Humax Pharmaceutical
INDUSTRY
Sponsor Role
collaborator
Universidad de Antioquia
OTHER
Sponsor Role
lead
Responsible Party
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Carlos Julio Montoya Guarin
Associated Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carlos J Montoya, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad de Antioquia
Maria T Rugeles, PhD
Role: STUDY_CHAIR
Universidad de Antioquia
Fabian A Jaimes, MD, PhD
Role: STUDY_DIRECTOR
Universidad de Antioquia
Locations
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Group of Immunovirology, Research Universitary Center, University of Antioquia
Medellín, Antioquia, Colombia
Site Status
Countries
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Colombia
References
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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 naive patients (NCT00721305). J Infect. 2012 Dec;65(6):549-58. doi: 10.1016/j.jinf.2012.10.016. Epub 2012 Oct 17.
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DERIVED
Montoya CJ, Jaimes F, Higuita EA, Convers-Paez S, Estrada S, Gutierrez F, Amariles P, Giraldo N, Penaloza 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.
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DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COLCIENCIAS 111540820508
Identifier Type: -
Identifier Source: org_study_id