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

NCT01348308

Last updated date
Study Location
Hôpital Henri Mondor
Creteil, , 94010, France
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV-1 Infection, AIDS
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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HIV-1 Infection, AIDSImmuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
NCT01348308
  1. Creteil,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
Official Title  ICMJE 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
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • HIV-1 Infection
  • AIDS
Intervention  ICMJE
  • 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.

Study Arms  ICMJE
  • Active Comparator: Maraviroc
    Maraviroc 300, 600 or 1200mg per day
    Intervention: Drug: Maraviroc (Celsentri)
  • Placebo Comparator: Placebo
    Placebo 300, 600 or 1200mg per day
    Intervention: Drug: Placebo
Publications * Lévy Y, Lelièvre 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, Béniguel 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2014)
407
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2011)
408
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01348308
Other Study ID Numbers  ICMJE 2010-022293-14
ANRS 146 OPTIMAL
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Yves Levy, MD, PhDAPHP, Hopital Henri Mondor, Creteil, France
Principal Investigator:Jean-Daniel Lelievre, MD, PhDAPHP, Hopital Henri Mondor, Creteil, France
Study Director:Dominique Costagliola, PhDINSERM U943 and Univerité Pierre et Marie Curie
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP