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

Hospital Clinic of Barcelona

Status and phase

Unknown

Phase 4

Conditions

HIV-1 Infection

Treatments

Drug: Maraviroc

Study type

Interventional

Funder types

Other

Identifiers

NCT01235013

DIS-MVC

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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