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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 and/or CD4 (Cluster of Differentiation 4) Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL
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.
Details
| Lead sponsor | ANRS, Emerging Infectious Diseases |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 407 |
| Start date | 2011-09 |
| Completion | 2016-03 |
Conditions
- HIV-1 Infection
- AIDS
Interventions
- Maraviroc (Celsentri)
- Placebo
Primary outcomes
- To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events — From Week 0 to Week 72
The clinical benefit is the reduction of occurence of a composite outcome consisting of: * New AID-defining event (1993 CDC(Centers for Disease Control) expanded surveillance definition) * Non B or C events (Aspergillosis, Bartonellosis, Chagas disease, Leishmaniasis, Lymphoma, Microsporidiosis chronic intestinal, Nocardiosis, Penicillium marneffei extrapulmonary, Pneumocystis jiroveci extrapulmonary, Rhodococcus equi disease, Severe bacterial infections) * Serious non-AIDS events (Cardiovascular disease, Chronic end stage renal disease, Liver failure, Non-AIDS defining cancers, IRIS) * All cause of mortality
Countries
France