drugset / Trial / NCT01348308

Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients

NCT01348308

Phase 3 Completed 407 enrolled ANRS, Emerging Infectious Diseases Pfizer · collab
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-09
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Maraviroc Other / unclassified 150 mg Oral
Comparator Maraviroc Other / unclassified 300 mg Oral
Comparator Maraviroc Other / unclassified 600 mg Oral

Indications