Skip to main content
OpenTrials
Completed

NCT Number: NCT01348308

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HIV-1 Infection AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital Henri Mondor

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed HIV-1 infection (ELISA and Western Blot tests positive)
  • CD4+ T lymphocytes below or equal 200/mm³ or previous AIDS-defining-illness at diagnosis
  • Patient naïve from any antiretroviral
  • In women, use of a contraceptive method, and lack of actual pregnancy
  • Patients with a coverage from social health
  • After informed consent

Exclusion criteria

  • Current pregnancy, lack of contraceptive method, breast-feeding
  • Current active tuberculosis (either suspected, diagnosed)
  • Ongoing malignancies except cutaneous Kaposi's sarcoma. Patients with a previous cancer considered as cured for at least 6 months could be included in the study
  • Current or previous severe cardiac failure, chronic respiratory disease, renal or liver insufficiency; any life-threatening organ failure
  • Cognitive impairment, psychiatric disorders, severe depressive affects, unadapted behavior
  • Use of cytostatic drugs, immunosuppressive agents, steroids
  • PMN (polymorphonuclear neutrophil) below 750/mm³, platelets below 50,000/mm³, haemoglobin below 10 g/dL; ASAT (aspartate aminotransferase), ALAT (alanine aminotransferase) or bilirubin over 2.5 ULN; lipase over 2 ULN (Upper limit of normal), serum creatinine over 1.5 ULN; proteinuria over 1g/L; INR (International Normalized Ratio) abnormal
  • Current or previous, during the 3 last months, use of immunomodulatory agents (G-CSF (granulocyte colony stimulating factor), IL-2 (Interleukin-2), GM-CSF (Granulocyte Macrophage colony stimulating factor), interferons, pentoxifylline)
  • Hypersensitivity to peanut and /or soy products

Treatment and study plan

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.

Placebo

Drug

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.

Primary outcomes

  1. To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events

    Time frame: 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

Secondary outcomes

  1. Safety evaluation and Clinical, Immunological and pharmacological evaluation

    Time frame: From Week 0 to Week 72

    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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: OPTIMAL

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 5, 2011
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.