Back to resultsLovastatin: Immunomodulatory Value Evaluation (LIVE)
Primary Purpose
HIV Seropositivity
Status
Completed
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Lovastatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for HIV Seropositivity focused on measuring Type 1 human immunodeficiency virus infection, Lovastatin, Adaptive Immunity, Cellular cholesterol, Rho GTPases, Lymphocyte function-associated antigen-1
Eligibility 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
Sites / Locations
- Group of Immunovirology, Research Universitary Center, University of Antioquia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
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
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)
Outcomes
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
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
Full Information
NCT ID
NCT00721305
First Posted
July 22, 2008
Last Updated
September 30, 2011
Sponsor
Universidad de Antioquia
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Laboratorio Clínico Congregación Mariana, Laboratorios Laproff S.A., Humax Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT00721305
Brief Title
Lovastatin: Immunomodulatory Value Evaluation
Acronym
LIVE
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 Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Antioquia
Collaborators
Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS), Laboratorio Clínico Congregación Mariana, Laboratorios Laproff S.A., Humax Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Seropositivity
Keywords
Type 1 human immunodeficiency virus infection, Lovastatin, Adaptive Immunity, Cellular cholesterol, Rho GTPases, Lymphocyte function-associated antigen-1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Lovastatin
Other Intervention Name(s)
statin
Intervention Description
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
Other
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos J Montoya, MD, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria T Rugeles, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabian A Jaimes, MD, PhD
Organizational Affiliation
Universidad de Antioquia
Official's Role
Study Director
Facility Information:
Facility Name
Group of Immunovirology, Research Universitary Center, University of Antioquia
City
Medellin
State/Province
Antioquia
Country
Colombia
12. IPD Sharing Statement
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