Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients - Full Text View

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:	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 Dr Laurent COTTE, Association Pour la Recherche en Infectiologie:

Primary Outcome Measures:

HIV-1 viral load [ Time Frame: 48 weeks ]
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 2015 (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 (Adult, Senior)
Sexes Eligible for Study:	All
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
Edourad Herriot hospital
Lyon, France, 69003
Croix Rousse hospital
Lyon, France, 69004
Ste MArguerite Hospital
MArseille, France, 13009
Conception hospital
Marseille, France, 13385
Hotel Dieu hospital
Nantes, France, 44093
Hopital l'Archet 1
Nice, France, 06202
St Louis Hospital
Paris, France, 75010
Pitie Salpetriere Hospital
Paris, France, 75013
Nord Hospital
St Etienne, France, 42277

Sponsors and Collaborators

Association Pour la Recherche en Infectiologie

Investigators


Principal Investigator:	Laurent COTTE, MD

More Information


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 29, 2015

Keywords provided by Dr Laurent COTTE, Association Pour la Recherche en Infectiologie:


HIV naive patients maraviroc raltegravir

Additional relevant MeSH terms:


Tenofovir Raltegravir Potassium Emtricitabine Maraviroc Antiviral Agents Anti-Infective Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors	Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Anti-HIV Agents HIV Integrase Inhibitors Integrase Inhibitors CCR5 Receptor Antagonists

ClinicalTrials.gov processed this record on July 24, 2017

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