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

January 26, 2011
December 10, 2012
September 2011
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01291459 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients
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

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.

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

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
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
Experimental: single arm
Maraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks
Intervention: Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
France
 
NCT01291459
2009/HD/01
Yes
Dr Laurent COTTE, Association Pour la Recherche en Infectiologie
Association Pour la Recherche en Infectiologie
Not Provided
Principal Investigator: Laurent COTTE, MD
Association Pour la Recherche en Infectiologie
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP