E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV naïve patients, CCR5 tropism, with CD4 > 200/mm3 and HIV RNA < 100 000 copy/ml. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020192 |
E.1.2 | Term | HIV-1 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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 < 50 copies/mL at each visit > W24 Viral kinetic decrease between baseline and W12 Clinical and biological safety at 48 weeks
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of the trial is the last visit of the last patient (when all patients will have reached W48 visit) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |