Ignite Creation Date:
2024-05-05 @ 11:02 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01235013
Status:
UNKNOWN
Last Update Posted:
2010-11-19
First Post:
2010-11-04
Brief Title:
Effect of Maraviroc MCV on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cellsmm3
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Effect of Maraviroc MCV on the Immunological Recovery of HIV-1 Discordant Patients With CD4 Lymphocyte Counts Below 200 Cellsmm3
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIS-MVC
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None