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

HIV-1 Infection Clinical Trial

— DIS-MVC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01235013
• Other study ID #: DIS-MVC
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 4, 2010
• Last updated: November 18, 2010

Study information

• Verified date: October 2010
• Source: Hospital Clinic of Barcelona
• Contact: José María Gatell, MD
• Phone: 0034932275400
• Email: jmgatell[@]clinic.ub.es
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic i Provincial	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median of CD4 counts change after 24 weeks		24 weeks	No
Secondary	Immunological profile	Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment	24 weeks	No
Secondary	CD4 counts	Number of pacients with CD4 counts over 200 cells/mm3	24 weeks	No
Secondary	Clinical progression	Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death	24 weeks	Yes