Lovastatin: Immunomodulatory Value Evaluation

NCT00721305 | Completed Phase 2 DMC

• 1 other identifier: COLCIENCIAS 111540820508
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Seropositivity

Keywords

Type 1 human immunodeficiency virus infection; Lovastatin; Adaptive Immunity; Cellular cholesterol; Rho GTPases; Lymphocyte function-associated antigen-1

Outcome Measures

Primary Outcomes (1)

• 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

  Before, 6 and twelve months after the intervention

Secondary Outcomes (1)

• 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

  Before, 6 and twelve months after the intervention

Study Arms (2)

1

EXPERIMENTAL

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

2

PLACEBO COMPARATOR

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

Interventions

Lovastatin 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

Also known as: statin

1

placebo 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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Antioquia: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator
• Laboratorio Clínico Congregación Mariana: collaborator
• Laboratorios Laproff S.A.: collaborator
• Humax Pharmaceutical: collaborator

Study Sites (1)

Group of Immunovirology, Research Universitary Center, University of Antioquia

Medellín, Antioquia, Colombia

Location

Related Publications (74)

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MeSH Terms

Conditions

HIV Seropositivity

Interventions

Lovastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Carlos J Montoya, MD, PhD

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

• Maria T Rugeles, PhD

  Universidad de Antioquia

  STUDY CHAIR

• Fabian A Jaimes, MD, PhD

  Universidad de Antioquia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-09

Locations

CO (1)