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

November 4, 2010
November 18, 2010
Not Provided
Not Provided
Median of CD4 counts change after 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01235013 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3
Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV-1 Infection
Drug: Maraviroc
150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
  • Experimental: Maraviroc
    Intervention: Drug: Maraviroc
  • No Intervention: Control
    Patients continue with their usual treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: José María Gatell, MD 0034932275400 jmgatell@clinic.ub.es
Contact: Judit Pich, Pharmacist 0034932275400 jpich@clinic.ub.es
Spain
 
NCT01235013
DIS-MVC
No
Dr. José María Gatell, Hospital Clínic i Provincial de Barcelona
Hospital Clinic of Barcelona
Not Provided
Principal Investigator: José Luis Blanco, MD Hospital Clínic i Provincial
Hospital Clinic of Barcelona
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP