Immuno-stimulation With Maraviroc Combined to Antiretrovi... | NCT01348308

NCT01348308

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
ANRS 146 OPTIMAL

Status Module

Name	Class
Pfizer	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Maraviroc	Active Comparator	Maraviroc 300, 600 or 1200mg per day	Drug: Maraviroc (Celsentri)
Placebo	Placebo Comparator	Placebo 300, 600 or 1200mg per day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Maraviroc (Celsentri)	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	From Week 0 to Week 72

Secondary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Yves Levy, MD, PhD	APHP, Hopital Henri Mondor, Creteil, France	Study Chair
Jean-Daniel Lelievre, MD, PhD	APHP, Hopital Henri Mondor, Creteil, France	Principal Investigator
Dominique Costagliola, PhD	INSERM U943 and Univerité Pierre et Marie Curie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Henri Mondor		Créteil		94010	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32040959	Derived	Levy Y, Lelievre JD, Assoumou L, Aznar E, Pulido F, Tambussi G, Crespo M, Meybeck A, Molina JM, Delaugerre C, Izopet J, Peytavin G, Cardon F, Diallo A, Lancar R, Beniguel L, Costagliola D. Addition of Maraviroc Versus Placebo to Standard Antiretroviral Therapy for Initial Treatment of Advanced HIV Infection: A Randomized Trial. Ann Intern Med. 2020 Mar 3;172(5):297-305. doi: 10.7326/M19-2133. Epub 2020 Feb 11.