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
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Condition or disease | Intervention/treatment | Phase |
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HIV Seropositivity | Drug: Lovastatin Other: placebo | Phase 2 |
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 |

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
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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)
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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 |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Asymptomatic HIV-1 seropositive individuals, with age ≥ 18 years, who are HAART naive
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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

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
Colombia | |
Group of Immunovirology, Research Universitary Center, University of Antioquia | |
Medellin, Antioquia, Colombia |
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 |
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 |
Other Study ID Numbers: |
COLCIENCIAS 111540820508 |
First Posted: | July 24, 2008 Key Record Dates |
Last Update Posted: | October 4, 2011 |
Last Verified: | September 2011 |
Type 1 human immunodeficiency virus infection Lovastatin Adaptive Immunity |
Cellular cholesterol Rho GTPases Lymphocyte function-associated antigen-1 |
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 |