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

NCT01348308 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 407

Last updated 2016-07-12

No results posted yet for this study

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.

Conditions

  • HIV-1 Infection
  • AIDS

Interventions

DRUG

Maraviroc (Celsentri)

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • ANRS, Emerging Infectious Diseases

    lead OTHER_GOV

Principal Investigators

  • Yves Levy, MD, PhD · APHP, Hopital Henri Mondor, Creteil, France

  • Jean-Daniel Lelievre, MD, PhD · APHP, Hopital Henri Mondor, Creteil, France

  • Dominique Costagliola, PhD · INSERM U943 and Univerité Pierre et Marie Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348308 on ClinicalTrials.gov