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

November 18, 2010 updated by: Hospital Clinic of Barcelona

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • HIV infection
  • Patients receiving HAART treatment for at least one year with a sustained viral load equal or below 200 copies/ml
  • Viral load equal or below 200 copies/ml at the screening visit
  • Discordant patients: patients without an increment over 50 copies /ml of CD4 lymphocytes during the last year
  • Patients with an expected adherence to HIV treatment over 90% according to their physician.
  • Signed informed consent form

Exclusion Criteria:

  • Pregnancy or breast feeding or women planning pregnancy during the study duration
  • Any contraindication to treatment with Maraviroc
  • X4 tropism at inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maraviroc
Drug: Maraviroc
150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
No Intervention: Control
Patients continue with their usual treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median of CD4 counts change after 24 weeks
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological profile
Time Frame: 24 weeks
Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment
24 weeks
CD4 counts
Time Frame: 24 weeks
Number of pacients with CD4 counts over 200 cells/mm3
24 weeks
Clinical progression
Time Frame: 24 weeks
Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: José Luis Blanco, MD, Hospital Clinic I Provincial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (Estimate)

November 5, 2010

Study Record Updates

Last Update Posted (Estimate)

November 19, 2010

Last Update Submitted That Met QC Criteria

November 18, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIS-MVC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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