We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
ClinicalTrials.gov Identifier:
NCT01235013
First Posted: November 5, 2010
Last Update Posted: November 19, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  Purpose

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: None (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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235013


Contacts
Contact: José María Gatell, MD 0034932275400 jmgatell@clinic.ub.es
Contact: Judit Pich, Pharmacist 0034932275400 jpich@clinic.ub.es

Locations
Spain
Hospital Clínic i Provincial Not yet recruiting
Barcelona, Spain, 08036
Contact: José María Gatell, MD    0034932275400    jmgatell@clinic.ub.es   
Contact: Judit Pich, Pharmacist    0034932275400    jpich@clinic.ub.es   
Principal Investigator: José Luis Blanco, MD         
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: José Luis Blanco, MD Hospital Clínic i Provincial
  More Information

Responsible Party: Dr. José María Gatell, Hospital Clínic i Provincial de Barcelona
ClinicalTrials.gov Identifier: NCT01235013     History of Changes
Other Study ID Numbers: DIS-MVC
First Submitted: November 4, 2010
First Posted: November 5, 2010
Last Update Posted: November 19, 2010
Last Verified: October 2010

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

Additional relevant MeSH terms:
Maraviroc
CCR5 Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents