E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 | 10008919 |
E.1.2 | Term | Chronic HIV infection |
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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 |
The primary objective is to confirm the hypothesis that Maraviroc stimulates immune recovery. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to explore, by virologic and immunologic investigations, the underlying mechanisms of this hypothesis (see main objective). |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Investigations using deuterated water in subset of study subjects participating in MIRS to investigate the physiology and kinetics of (CD4+) T-cell proliferation in more detail. Version may 25, 2009.
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E.3 | Principal inclusion criteria |
-Age 18 years or older -HAART with a maximal treatment interruption of two weeks -viral suppression (< 50 copies/ml) for 6 months
And either: -CD+ count < 200 cells/microl after minimal one year of treatment with HAART (study group one)
Or: -a CD4+ cell count between 200 and 350 cells/microl after minimal two years of treatment with HAART (studygroup two)
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E.4 | Principal exclusion criteria |
-Previous use of maraviroc -HIV-2 infection -HAART consisting of a combination of tenofovir and didanosine -Active infection for which antimicrobial treatment -Acute hepatitis B or C -Chronic hepatitis B or C for which treatment with (peg)interferon and/or ribavirine (Note: patients with untreated chronic hepatitis B or C can be included) -Immunosuppressive medication -Radiotherapy or chemotherapy in the past 2 years -Pregnancy or breastfeeding an infant -Subjects with known hypersensitivity to Maraviroc or to peanuts, or any of its excipients or dyes as follows: • Excipiens from tablet: microcrystalline cellulose, dibasic calcium phosphate (anhydrous), sodium starch glycolate, magnesium stearate. • Film-coat: [Opadry II Blue (85G20583) contains FD&C blue #2 aluminium lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc and titanium dioxide.
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E.5 End points |
E.5.1 | Primary end point(s) |
A 30% increase of the amount CD4+ cells in the treatment group compared with the placebo group (for both study groups). |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
immunologic and virologisc mechanisms |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 12 |
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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Trial ends after 1 year (48 weeks) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |