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

NCT01235013 | Unknown Phase 4

• 1 other identifier: DIS-MVC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-1 Infection

Keywords

HIV-1 infection; Maraviroc; CD4 lymphocyte count

Outcome Measures

Primary Outcomes (1)

• Median of CD4 counts change after 24 weeks

  24 weeks

Secondary Outcomes (3)

• Immunological profile

  24 weeks

• CD4 counts

  24 weeks

• Clinical progression

  24 weeks

Study Arms (2)

Maraviroc

EXPERIMENTAL

Drug: Maraviroc

Control

NO INTERVENTION

Patients continue with their usual treatment

Interventions

Maraviroc DRUG

150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks

Maraviroc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic i Provincial

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Maraviroc

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• José Luis Blanco, MD

  Hospital Clínic i Provincial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

José María Gatell, MD

CONTACT

0034932275400; jmgatell@clinic.ub.es

Judit Pich, Pharmacist

CONTACT

0034932275400; jpich@clinic.ub.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 5, 2010
• Last Updated: November 19, 2010

Record last verified: 2010-10

Locations

ES (1)