NCT01348308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
407

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 12, 2016

Status Verified

July 1, 2016

Enrollment Period

4.5 years

First QC Date

May 2, 2011

Last Update Submit

July 11, 2016

Conditions

HIV-1 InfectionAIDS

Keywords

Late diagnosed HIV-1 infected patientsAIDS-defining eventsImmune restoration

Outcome Measures

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

    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 (1)

  • Safety evaluation and Clinical, Immunological and pharmacological evaluation

    From Week 0 to Week 72

Study Arms (2)

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

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.

Maraviroc
PlaceboDRUG

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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Henri Mondor

Créteil, 94010, France

Location

Related Publications (1)

  • 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.

    PMID: 32040959DERIVED

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Maraviroc

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 5, 2011

Study Start

September 1, 2011

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 12, 2016

Record last verified: 2016-07

Locations

FR(1)