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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 because the information has not been verified recently.
Verified October 2010 by Hospital Clinic of Barcelona.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01235013
First received: November 4, 2010
Last updated: November 18, 2010
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
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:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Maraviroc
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunological profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment

  • CD4 counts [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Number of pacients with CD4 counts over 200 cells/mm3

  • Clinical progression [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 4, 2010
Last Updated: November 18, 2010
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013