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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 (DIS-MVC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Hospital Clinic of Barcelona.
Recruitment status was:  Not yet recruiting
Information provided by:
Hospital Clinic of Barcelona Identifier:
First received: November 4, 2010
Last updated: November 18, 2010
Last verified: October 2010

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.

Condition Intervention Phase
HIV-1 Infection
Drug: Maraviroc
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3

Resource links provided by NLM:

Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Median of CD4 counts change after 24 weeks [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • Immunological profile [ Time Frame: 24 weeks ]
    Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment

  • CD4 counts [ Time Frame: 24 weeks ]
    Number of pacients with CD4 counts over 200 cells/mm3

  • Clinical progression [ Time Frame: 24 weeks ]
    Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death

Estimated Enrollment: 60
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01235013

Hospital Clínic i Provincial
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Principal Investigator: José Luis Blanco, MD Hospital Clínic i Provincial
  More Information

Responsible Party: Dr. José María Gatell, Hospital Clínic i Provincial de Barcelona Identifier: NCT01235013     History of Changes
Other Study ID Numbers: DIS-MVC 
Study First Received: November 4, 2010
Last Updated: November 18, 2010

Keywords provided by Hospital Clinic of Barcelona:
HIV-1 infection
CD4 lymphocyte count

Additional relevant MeSH terms:
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents processed this record on February 20, 2017