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Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3

NCT01235013 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2010-11-19

No results posted yet for this study

Summary

Maraviroc is an antiretroviral drug that belongs to the family of the CCR5 coreceptor inhibitors. It has proven to be effective in increasing CD4 lymphocyte counts in both in treated and naïve patients, irrespective of the viral load.

The investigators hypothesize that adding Maraviroc to the antiretroviral treatment of discordant patients, defined as those having CD4 lymphocyte counts below 200 cells /mm3 during the last year, could lead to its immunological recovery.

60 patients will be included in this unicentric, prospective, randomized and stratified clinical trial. They will be randomized to either continue with its usual high activity antiretroviral therapy (HAART) treatment or to receive 300 mg of Maraviroc every 12 hours plus its usual treatment. After 24 weeks, lymphocyte counts will be assessed, as well as safety, clinical progression, immunological profile of the patients and the potential benefit of Maraviroc for HIV+ cirrhotic patients.

Conditions

  • HIV-1 Infection

Interventions

DRUG

Maraviroc

150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • José Luis Blanco, MD · Hospital Clínic i Provincial

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Spain

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 NCT01235013 on ClinicalTrials.gov