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:
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
  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:


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:
  • Maraviroc
  • Raltegravir
  • Emtricitabine
  • Tenofovir

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 April 21, 2014