Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3 (DIS-MVC)
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|ClinicalTrials.gov Identifier: NCT01235013|
Recruitment Status : Unknown
Verified October 2010 by Hospital Clinic of Barcelona.
Recruitment status was: Not yet recruiting
First Posted : November 5, 2010
Last Update Posted : November 19, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|HIV-1 Infection||Drug: Maraviroc||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Maraviroc (MCV) on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cells/mm3|
150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
No Intervention: Control
Patients continue with their usual treatment
- Median of CD4 counts change after 24 weeks [ Time Frame: 24 weeks ]
- Immunological profile [ Time Frame: 24 weeks ]Immunohistochemistry and flow cytometry techniques will be performed on peripheral blood to study immunological response to Maraviroc treatment
- CD4 counts [ Time Frame: 24 weeks ]Number of pacients with CD4 counts over 200 cells/mm3
- Clinical progression [ Time Frame: 24 weeks ]Progression to diseases classified as category C in CDC HIV guidelines; to other diseases or patient death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01235013
|Contact: José María Gatell, MDfirstname.lastname@example.org|
|Contact: Judit Pich, Pharmacistemail@example.com|
|Hospital Clínic i Provincial||Not yet recruiting|
|Barcelona, Spain, 08036|
|Contact: José María Gatell, MD 0034932275400 firstname.lastname@example.org|
|Contact: Judit Pich, Pharmacist 0034932275400 email@example.com|
|Principal Investigator: José Luis Blanco, MD|
|Principal Investigator:||José Luis Blanco, MD||Hospital Clínic i Provincial|