Trial record 1 of 29 for:
" July 16, 2008":" August 15, 2008"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Lovastatin: Immunomodulatory Value Evaluation (LIVE)
This study has been completed.
Sponsor:
Universidad de Antioquia
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
complement factor I deficiency
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
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
Publications:
Illingworth DR, Tobert JA. HMG-CoA reductase inhibitors. Adv Protein Chem 2001;56:77-114
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
Lovastatin Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013