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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
407
Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Maraviroc at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen. Duration: 72 weeks.
Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Placebo at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen. Duration: 72 weeks.
Hôpital Henri Mondor
Créteil, France
To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events
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
Time frame: From Week 0 to Week 72
Safety evaluation and Clinical, Immunological and pharmacological evaluation
The secondary end points: * Clinical events (to compare Maraviroc and placebo arm for each component of the primary composite endpoint and other major outcomes) * Immunological evaluation (T cells phenotypic analysis; seric markers of immune activation) * Virological evaluation (plasma HIV viral load analysis; viral tropism testing,) * Pharmacokinetic evaluation (plasma concentration of Maraviroc and relationship with virological response) * Clinical and biological safety of the strategy (Adverse events \>= grade 2 on ANRS scale of adverse event) * Cost-effectiveness analysis
Time frame: From Week 0 to Week 72
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