HIV-1 Infection Clinical Trial
— OPTIMALOfficial 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
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.
Status | Completed |
Enrollment | 407 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Hôpital Henri Mondor | Creteil |
Lead Sponsor | Collaborator |
---|---|
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS) | Pfizer |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Safety evaluation and Clinical, Immunological and pharmacological evaluation | 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 |
From Week 0 to Week 72 | Yes |
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