Ignite Creation Date:
2024-05-05 @ 11:30 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01348308
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2011-05-02
Brief Title:
Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
Sponsor:
ANRS Emerging Infectious Diseases
Organization:
ANRS Emerging Infectious Diseases
Study Overview
Official Title:
Optimized Phase III Trial of Immuno-stimulation With Maraviroc a CCR5 Chemokine Receptor 5 Antagonist Combined With Anti Retroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event andor CD4 Cluster of Differentiation 4 Counts Below 200 Cellsmm³ ANRS 146 OPTIMAL
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
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:
OPTIMAL
Brief Summary:
The objective of the OPTIMAL study is to demonstrate that the adjunction of Maraviroc to a combination of antiretroviral therapy in naive and late diagnosed HIV-1 infected patients counts may accelerate the kinetics of immune restoration and decrease the risk of disease progression and death
It is a randomized versus placebo double-blind trial conducted in France Spain and Italy
It is a randomized versus placebo double-blind trial conducted in France Spain and Italy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANRS 146 OPTIMAL | None | None | None |