Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients (NNNB)

This study is ongoing, but not recruiting participants.
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: May 27, 2014
Last verified: May 2014
  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: December 2015
Estimated Primary Completion Date: December 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. PAtients with occult HBV are excluded.( positive AcHBc, negative AcHBs, negative AgHBs, positive HBV DNA)
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291459

Locations
France
Cannes hosipital
CAnnes, France, 06400
CHU
Clermont-Ferrand, France, 63003
Frejus hospital
Frejus, France, 83608
Croix Rousse hospital
Lyon, France, 69004
Edourad Herriot hospital
Lyon, France, 69003
Ste MArguerite Hospital
MArseille, France, 13009
Conception hospital
Marseille, France, 13385
Hotel Dieu hospital
Nantes, France, 44093
Hopital l'Archet 1
Nice, France, 06202
Pitie Salpetriere Hospital
Paris, France, 75013
St Louis Hospital
Paris, France, 75010
Nord Hospital
St Etienne, France, 42277
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: May 27, 2014
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:
Emtricitabine
Tenofovir
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014