Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients
NCT01348308
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| 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 | 407 | |||||||||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 | ANRS, Emerging Infectious Diseases | |||||||||
| Study Sponsor ICMJE | ANRS, Emerging Infectious Diseases | |||||||||
| Collaborators ICMJE | Pfizer | |||||||||
| Investigators ICMJE |
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| PRS Account | ANRS, Emerging Infectious Diseases | |||||||||
| Verification Date | July 2016 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||