Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients (OPTIMAL)
This study is currently recruiting participants.
Verified December 2011 by French National Agency for Research on AIDS and Viral Hepatitis
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborator:
Pfizer
Information provided by (Responsible Party):
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT01348308
First received: May 2, 2011
Last updated: December 21, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV-1 Infection AIDS |
Drug: Maraviroc (Celsentri) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Optimized Phase III Trial of Immuno-stimulation With Maraviroc, a CCR5 Antagonist, Combined With Anti Retroviral Therapy in Advanced, Late Diagnosed HIV-1 Infected Patients With an AIDS-defining Event and/or CD4 Counts Below 200 Cells/mm³. ANRS 146 OPTIMAL |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Maraviroc
U.S. FDA Resources
Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:
Primary Outcome Measures:
- To demonstrate the clinical benefit of the adjunction of Maraviroc to a combination of antiretroviral therapy defined as decrease of clinical events [ Time Frame: From Week 0 to Week 72 ] [ Designated as safety issue: No ]
The clinical benefit is the reduction of occurence of a composite outcome consisting of:
- New AID-defining event (1993 CDC expanded surveillance definition)
- Non B or C events (Aspergillosis, Bartellosis, Chagas disease, Leishmaniasis, Lymphoma, Microsporidiosis chronic intestinal, Nocardiosis, Penicillium marnefeei 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:
- Safety evaluation and Clinical, Immunological and pharmacological evaluation [ Time Frame: From Week 0 to Week 72 ] [ Designated as safety issue: Yes ]
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
| Estimated Enrollment: | 408 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Maraviroc |
Drug: Maraviroc (Celsentri)
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 EFV-based regimen. Duration: 72 weeks. |
| Placebo Comparator: Placebo |
Drug: Placebo
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 EFV-based regimen. Duration: 72 weeks. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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, inadapted behavior
- Use of cytostatic drugs, immunosuppressive agents, steroids
- PMN below 750/mm³, platelets below 50,000/mm³, haemoglobin below 10 g/dL; ASAT, ALAT or bilirubin over 2.5 ULN; lipase over 2 ULN, serum creatinine over 1.5 ULN; proteinuria over 1g/L; INR abnormal
- Current or previous, during the 3 last months, use of immunomodulatory agents (G-CSF, IL-2, GM-CSF, interferons, pentoxifylline)
- Hypersensitivity to peanut and /or soy products
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348308
Contacts
| Contact: Yves Levy, MD, PhD | 0033149812455 | yves.levy@hmn.aphp.fr |
| Contact: Lydie Beniguel, PhD | 0033142164268 | lbeniguel@ccde.chups.jussieu.fr |
Locations
| France | |
| Hôpital Henri Mondor | Recruiting |
| Creteil, France, 94010 | |
| Contact: Jean-Daniel Lelievre, MD, PhD | |
| Principal Investigator: Jean-Daniel Lelievre, MD, PhD | |
Sponsors and Collaborators
French National Agency for Research on AIDS and Viral Hepatitis
Pfizer
Investigators
| Study Chair: | Yves Levy, MD, PhD | APHP, Hopital Henri Mondor, Creteil, France |
| Principal Investigator: | Jean-Daniel Lelievre, MD, PhD | APHP, Hopital Henri Mondor, Creteil, France |
| Study Director: | Dominique Costagliola, PhD | INSERM U943 and Univerité Pierre et Marie Curie |
More Information
Additional Information:
No publications provided
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01348308 History of Changes |
| Other Study ID Numbers: | 2010-022293-14, ANRS 146 OPTIMAL |
| Study First Received: | May 2, 2011 |
| Last Updated: | December 21, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Italy: The Italian Medicines Agency Spain: Spanish Agency of Medicines |
Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:
|
Late diagnosed HIV-1 infected patients AIDS-defining events Immune restoration |
Additional relevant MeSH terms:
|
Acquired Immunodeficiency Syndrome HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013