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Lovastatin: Immunomodulatory Value Evaluation

NCT00721305 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2011-10-04

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Laboratorio Clínico Congregación Mariana

    collaborator OTHER

  • Laboratorios Laproff S.A.

    collaborator INDUSTRY

  • Humax Pharmaceutical

    collaborator INDUSTRY

  • Universidad de Antioquia

    lead OTHER

Principal Investigators

  • Carlos J Montoya, MD, PhD · Universidad de Antioquia

  • Maria T Rugeles, PhD · Universidad de Antioquia

  • Fabian A Jaimes, MD, PhD · Universidad de Antioquia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00721305 on ClinicalTrials.gov