Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients (NNNB)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01291459 |
Recruitment Status
: Unknown
Verified December 2015 by Dr Laurent COTTE, Association Pour la Recherche en Infectiologie.
Recruitment status was: Active, not recruiting
First Posted
: February 8, 2011
Last Update Posted
: December 30, 2015
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2011 |
Estimated Primary Completion Date : | December 2015 |
Estimated Study Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
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:
|
- HIV-1 viral load [ Time Frame: 48 weeks ]measure of HIV viral load at 48 weeks of treatment for all patients

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01291459
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 |
Principal Investigator: | Laurent COTTE, MD |
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 |
First Posted: | February 8, 2011 Key Record Dates |
Last Update Posted: | December 30, 2015 |
Last Verified: | December 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 |