HIV naïve patients, CCR5 tropism, with CD4 > 200/mm3 and HIV RNA < 100 000 copy/ml. MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: ISENTRESS
Product Name: Raltegravir
Pharmaceutical Form: Tablet
Trade Name: CELSENTRI
Product Name: Maraviroc
Pharmaceutical Form: Tablet
Trade Name: TRUVADA
Product Name: Tenofovir/Emtr
Sponsors
P Pierre Dellamonica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Age = 18 years of age at the pre-screening visit ? Infected with HIV-1 ? Receiving antiretroviral treatment for the first time ? HIV RNA = 1,000 copies/mL ? Indication of antiretroviral treatment based on 2008 guidelines ? CCR5-tropic virus detected with the Trofile ES® test ? No significant resistance mutations to NRTI, NNRTI and PI ? Free, informed and written consent signed by the patient and investigator (the day of pre-screening at the latest and before any test required by the trial) ? Person affiliated or benefiting from a health insurance plan Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Women of childbearing potential without effective contraceptive (mechanical contraceptive) ? Pregnant or breast-feeding women ? Previous antiretroviral treatment (with the exception of post-exposure prophylaxis in case of negative HIV blood test > 3 months following the last dose of antiretrovirals) ? CXCR4 tropic, dual/mixed or non-reportable virus on screening ? Presence of significant mutation(s) of resistance to NRTI, NNRTI or to PI ? Infection or coinfection with HIV-2, groups O or N of the virus ? Opportunistic infection in acute phase ? Tuberculosis with treatment in progress ? Neoplastic disease with treatment in progress with chemotherapy and/or radiation therapy ? Decompensated cirrhosis (Child-Pugh score of class B and C) ? Coinfection of HIV-HBV. Patients with a coinfection of HIV-HCV are authorized if there is no decompensated cirrhosis (Child-Pugh score of class B and C), no hepatic cytolysis > 3 times the upper limit of normal and no indication for treatment of the HCV in the next 12 months. ? Coadministration of prohibited treatments ? Biological parameters: Hemoglobin < 7g/dL, polynuclear neutrophils < 500/mm3, platelets < 50,000/mm3, creatinine clearance < 50 mL/mn, alkaline phosphatases, AST, ALT or bilirubin = 3 times the upper limit of normal ? Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Virological efficacy at W48 of a simplification strategy with combination of Maraviroc and Raltegravir after 6 months of quadruple therapy with the combination of Maraviroc, Raltegravir, Tenofovir and Emtricitabine in patients infected with HIV-1, receiving antiretroviral treatment for the first time, with a CCR5-tropic virus. (ITT analysis);Secondary Objective: Virological efficacy at W48 of a simplification strategy with combination of Maraviroc and Raltegravir after 6 months of quadruple therapy with the combination of Maraviroc, Raltegravir, Tenofovir and Emtricitabine in patients infected with HIV-1, receiving antiretroviral treatment for the first time, with a CCR5-tropic virus. (analysis on patients who underwent the simplification phase) Immunological efficacy at W48 Time until treatment failure > W24 Proportion of patients with plasma HIV-1 RNA W24 Viral kinetic decrease between baseline and W12 Clinical and biological safety at 48 weeks ;Primary end point(s): ? The primary endpoint is virological failure defined by plasma HIV RNA = 50 copies/mL over 2 consecutive samples taken at an interval of 2 weeks. The proportion of patients having presented a virological failure or having exited the study before week 48 will be analyzed at W48 (Intention to treat analysis). | — |
Countries
France
Outcome results
None listed