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

Study Overview
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Brief Summary
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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.

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

Conditions
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HIV-1 Infection

Intervention / Treatment
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* Drug: Maraviroc


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maraviroc<br> | Drug: Maraviroc<br>* 150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks<br>|
| No Intervention: Control<br>Patients continue with their usual treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median of CD4 counts change after 24 weeks |  | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-1 infection, Maraviroc, CD4 lymphocyte count