Pilot Study of Maraviroc/Raltegravir for Naive HIV-1 Patients
NCT ID: NCT01291459
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2011-09-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
single arm
Maraviroc/raltegravir/emtricitabine/tenofovir 24 weeks followed by Maraviroc/Raltegravir 24 weeks
MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir
MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Association Pour la Recherche en Infectiologie
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Laurent COTTE
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laurent COTTE, MD
Role: PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cannes hosipital
Cannes, , France
CHU
Clermont-Ferrand, , France
Frejus hospital
Fréjus, , France
Edourad Herriot hospital
Lyon, , France
Croix Rousse hospital
Lyon, , France
Ste MArguerite Hospital
Marseille, , France
Conception hospital
Marseille, , France
Hotel Dieu hospital
Nantes, , France
Hopital l'Archet 1
Nice, , France
St Louis Hospital
Paris, , France
Pitie Salpetriere Hospital
Paris, , France
Nord Hospital
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009/HD/01
Identifier Type: -
Identifier Source: org_study_id