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

Phase 4

• Conditions: HIV-1 Infection
• Interventions: Drug: Maraviroc

• Registration Number: NCT01235013
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-10
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maraviroc	Maraviroc	-

Primary Outcome Measures

Name	Time	Method
Median of CD4 counts change after 24 weeks	24 weeks

Secondary Outcome Measures

Name	Time	Method
Immunological profile	24 weeks	Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment
CD4 counts	24 weeks	Number of pacients with CD4 counts over 200 cells/mm3
Clinical progression	24 weeks	Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death

Trial Locations

Locations (1)

Hospital Clínic i Provincial; 🇪🇸 Barcelona, Spain