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

Phase 3

Completed

• Conditions: HIV-1 Infection; AIDS
• Interventions: Drug: Placebo; Drug: Maraviroc (Celsentri)

• Registration Number: NCT01348308
• Lead Sponsor: ANRS, Emerging Infectious Diseases

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 available

Study Timeline

• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-04
• Study First Posted: 2011-05-05
• Study Start: 2011-09
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 407

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 300, 600 or 1200mg per day
Maraviroc	Maraviroc (Celsentri)	Maraviroc 300, 600 or 1200mg per day

Primary Outcome Measures

Name	Time	Method
To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events	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 Outcome Measures

Name	Time	Method
Safety evaluation and Clinical, Immunological and pharmacological evaluation	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

Trial Locations

Locations (1)

Hôpital Henri Mondor; 🇫🇷 Creteil, France