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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ANRS, Emerging Infectious Diseases; French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Collaborator: Pfizer
• Treatments: Maraviroc; Protease Inhibitors

Criteria

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