Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients (NNNB)
This study is currently recruiting participants.
Verified December 2012 by Association Pour la Recherche en Infectiologie
Sponsor:
Association Pour la Recherche en Infectiologie
Information provided by (Responsible Party):
Dr Laurent COTTE, Association Pour la Recherche en Infectiologie
ClinicalTrials.gov Identifier:
NCT01291459
First received: January 26, 2011
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
Background and Rationale
Raltegravir and Maraviroc, the first in class of 2 new families of antiretroviral drugs have demonstrated a high potency in treatment experienced and naive patients. Both drugs appeared well tolerated with low metabolic toxicity. No data are currently available concerning the combination of these 2 drugs.
Hypothesis
Maraviroc + Raltegravir should be potent enough to maintain virological efficacy in naive patients infected by CCR5 HIV-1 previously treated for 6 months with a Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Pilot Study of Simplification to Maraviroc - Raltegravir Dual Therapy After 6 Months of Maraviroc - Raltegravir - Tenofovir - Emtricitabine Quadruple Therapy in ARV Treatment-naive, HIV-1-infected Patients With CCR5- Virus |
Resource links provided by NLM:
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Emtricitabine
Tenofovir
Tenofovir Disoproxil Fumarate
Maraviroc
Raltegravir
Raltegravir potassium
U.S. FDA Resources
Further study details as provided by Association Pour la Recherche en Infectiologie:
Primary Outcome Measures:
- HIV-1 viral load [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]measure of HIV viral load at 48 weeks of treatment for all patients
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: single arm
Maraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks
|
Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.
Other Names:
|
Detailed Description:
Objectives:
- To establish the ability of a Maraviroc-Raltegravir combination to maintain HIV-1 viral load < 50 copies/ml at week 48 in naive patients infected by CCR5 HIV-1, following an initial 6 month phase of Maraviroc-Raltegravir-Tenofovir-Emtricitabine combination (Intent to treat and strategy analysis)
- To study CD4 progression from baseline to week 48
- To study the time to virological failure during the simplification phase of the study (from week 24 to week 48)
- To study the proportion of patients with HIV RNA < 50 copies/ml at each time point
- To study the kinetics of viral load decrease from baseline to week 12
- To study the kinetics of proviral DNA decrease from baseline to week 12, 24, 36 and 48
- To study the clinical and biological tolerance of Maraviroc-Raltegravir combination through week 48
Study Design/ Clinical Plan
Pilot, multicenter, national, uncontrolled study
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years old at the run-in visit
- HIV-1 infection
- Antiretroviral treatment-naive
- CD4 ≥ 200 /mm3
- HIV- RNA ≥ 1000 copies/ml
- HIV-RNA ≤ 100,000 copies/ml
- Antiretroviral therapy is indicated according to current guidelines
- CCR5-tropic virus according to the Trofile ES® assayGeno2Pheno algorithm using a predefined false positive rate of 20%
- No significant NRTI, NNRTI or PI resistance mutation
- Freely-given, written, informed consent obtained; the patient and investigator have signed the consent form (by the latest on the day of the run-in visit and before performing any examinations required by the trial)
- Patient covered by a French national health insurance scheme
Exclusion Criteria:
- Women of child-bearing potential not using effective contraception (barrier method)
- Pregnant or breast-feeding women
- Patients under the age of 18 years
- Patients deprived of liberty by a judicial or administrative, hospitalized patients without consent, patients admitted to a health or social purposes other than research
- Persons major subject of a measure of legal protection or unable to consent
- Previous antiretroviral therapy (with the exception of post-exposure prophylaxis if HIV serology is negative > 3 months after the last dose of antiretroviral drugs)
- CXCR4-tropic virus, dual/mixed-tropic virus or undetermined tropism on screening
- Presence of significant NRTI, NNRTI or PI resistance mutation(s)
- Infection or co-infection with HIV-2, or group O or N HIV-1
- Acute phase of an opportunistic infection
- Undergoing treatment for tuberculosis
- Undergoing chemotherapy and/or radiotherapy for neoplastic disease
- Decompensated cirrhosis (Child-Pugh class B or C)
- HIV-HBV co-infection. Patients with HIV-HCV co-infection are permitted to participate in the absence of decompensated cirrhosis (Child-Pugh class B or C), of hepatocytolysis > 3 times the upper limit of normal and if treatment for HCV during the ensuing 12 months is not indicated.
- Co-administration of prohibited treatments (see the SPCs of each product) Laboratory parameters: Haemoglobin < 7g/dl, neutrophil count < 500/mm3, platelet count < 50,000/mm3, creatinine clearance < 50 ml/min, alkaline phosphatase, AST, ALT or bilirubin ≥ 3 times upper limit of normal
- Patient refuses to participate
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01291459
Contacts
| Contact: Laurent Cotte, MD | 00 33 4 26 73 26 56 | laurent.cotte@chu-lyon.fr |
| Contact: Corinne Brochier, Pharm MD | 00 33 4 26 73 27 31 | corinne.brochier@chu-lyon.fr |
Locations
| France | |
| Cannes hosipital | Not yet recruiting |
| CAnnes, France, 06400 | |
| Contact: Nathalie Montagne, MD | |
| Principal Investigator: Nathalie Montagne, MD | |
| CHU | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Christine JACOMET, MD | |
| Principal Investigator: Christine JACOMET, MD | |
| Frejus hospital | Not yet recruiting |
| Frejus, France, 83608 | |
| Contact: Pascal Del Giudice, MD | |
| Principal Investigator: Pascal Del Giudice, MD | |
| Croix Rousse hospital | Recruiting |
| Lyon, France, 69004 | |
| Contact: Laurent Cotte, MD ++ 33 26 73 26 56 laurent.cotte@chu-lyon.fr | |
| Principal Investigator: Laurent Cotte | |
| Edourad Herriot hospital | Not yet recruiting |
| Lyon, France, 69003 | |
| Contact: Jean Michel LIVROZET, MD | |
| Principal Investigator: Jean Michel LIVROZET | |
| Conception hospital | Not yet recruiting |
| Marseille, France, 13385 | |
| Contact: Isabelle Ravaux, MD | |
| Principal Investigator: Isabelle Ravaux, MD | |
| Hotel Dieu hospital | Recruiting |
| Nantes, France, 44093 | |
| Contact: Francois RAFFI, MD | |
| Principal Investigator: Francois RAFFI, MD | |
| Hopital l'Archet 1 | Recruiting |
| Nice, France, 06202 | |
| Contact: Jacques DURANT, MD 00 33 4 92 03 55 14 durant.j@chu-nice.fr | |
| Principal Investigator: Jacques DURANT, MD | |
| St Louis Hospital | Not yet recruiting |
| Paris, France, 75010 | |
| Contact: Jean Michel MOLINA, MD | |
| Principal Investigator: Jean Michel MOLINA, MD | |
| Pitie Salpetriere Hospital | Not yet recruiting |
| Paris, France, 75013 | |
| Contact: Christine KATLAMA, MD | |
| Principal Investigator: Christine KATLAMA, MD | |
| Nord Hospital | Not yet recruiting |
| St Etienne, France, 42277 | |
| Contact: Frederic LUCHT, MD | |
| Principal Investigator: Frederic LUCHT, MD | |
Sponsors and Collaborators
Association Pour la Recherche en Infectiologie
Investigators
| Principal Investigator: | Laurent COTTE, MD |
More Information
No publications provided
| Responsible Party: | Dr Laurent COTTE, MD, Association Pour la Recherche en Infectiologie |
| ClinicalTrials.gov Identifier: | NCT01291459 History of Changes |
| Other Study ID Numbers: | 2009/HD/01 |
| Study First Received: | January 26, 2011 |
| Last Updated: | December 10, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Association Pour la Recherche en Infectiologie:
|
HIV naive patients maraviroc raltegravir |
Additional relevant MeSH terms:
|
Tenofovir Tenofovir disoproxil Emtricitabine Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013