E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV infection (R5 tropism only) with previous therapy |
Infezione da HIV (tropismo R5 puro) pretrattati. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
To confirm the hypothesis that vicriviroc 30 mg QD provides added benefit in plasma HIV-1 RNA reduction when added to optimized background therapy (OBT), as measured by the proportion of subjects with HIV RNA <50 copies/mL at Week 48. |
Confermare l'ipotesi che vicriviroc 30 mg QD fornisca un beneficio addizionale in combinazione con una OBT nel ridurre l'HIV-RNA plasmatico valutando la proporzione di pazienti con HIV-RNA < 50 copie/mL alla settimana 48. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety and tolerability of vicriviroc compared to placebo, each in combination with OBT. |
Valutazione di sicurezza e tollerabilita' di vicriviroc rispetto a placebo,entrambi in combinazione con OBT. |
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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 |
PHARMACOGENETIC: Vers: Date: Title: Objectives:
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FARMACOGENETICA: Vers: Data: Titolo: Obiettivi:
|
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E.3 | Principal inclusion criteria |
1) Subjects must be at least 16 years of age (or minimum age as determined by local regulatory authorities at time of randomization, of either sex, and of any race 2) Subjects must be infected with HIV-1 virus as documented by a positive assay for HIV-1 RNA in plasma 3) Subjects must have plasma HIV-1 RNA >1000 copies/mL within 60 days of randomization either on a stable regimen of 3 or more antiretroviral drugs for at least 4 weeks at time of screening or not on any antiretroviral agents for greater than or equal to 4 weeks prior to screening 4) Subjects must be ART-experienced and have documented resistance to at least 2 of the following 3 drug classes: NRTI, NNRTI or PI or antiretroviral class experience for at least 6 months with each of the drug classes mentioned. |
1. pazienti che al momento della randomizzazione abbiano almeno 16 anni di eta' (o almeno l'eta' minima prevista dalle Autorita' regolatorie nazionali o dalla legge locale vigente), di entrambi i sessi e di qualsiasi razza; 2. pazienti con infezione da HIV-1 documentata da un test positivo per HIV-RNA nel plasma prima dello screening. 3. pazienti che presentino un HIV-1 RNA > 1000 copie/mL nei 60 giorni dalla randomizzazione o a. che al momento dello screening siano in trattamento con un regime di farmaci antiretrovirali comprendente 3 o piu' farmaci per almeno 4 settimane o b. che per un periodo >=; 4 settimane prima dello screening non siano stati sottoposti ad un trattamento antiretrovirale; 4. pazienti che siano stati pretrattati con un regime ART ed abbiano una resistenza documentata (determinata dal test Monogram GeneSEq o PhenoSense HIV Drug Resistance) per almeno 2 delle 3 classi di farmaci riportate di seguito: NRTI, NNRTI, o PI oppure pazienti che siano stati sottoposti a pregresso trattamento (sequenziale o cumulativo) della durata di almeno 6 mesi con antiretrovirali appartenenti ad ognuna delle seguenti classi: NRTI, NNRTI, PI. |
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E.4 | Principal exclusion criteria |
1) Subjects must not have detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening (i.e. HIV isolate must be solely CCR5-tropic) 2) Subjects must not have any condition that, in the opinion of the investigator, is likely to increase the risk of seizures 3) Subjects must not have a prior history of malignancy (with the exceptions of surgically resected basal-cell carcinoma or cutaneous Kaposi's sarcoma without visceral or mucosal inlvolement that resolved without systemic anticancer treatment). |
1. pazienti con virus HIV con tropismo determinabile CXCR4 o duplice misto CCR5/CXCR4 (l'HIV isolato allo screening deve presentare esclusivamente un tropismo CCR5); 2. pazienti affetti da malattia convulsiva che richieda terapia anticonvulsivante attuale o da qualsiasi condizione che, a giudizio dello sperimentatore, possa verosimilmente aumentare il rischio di convulsioni (es. neoplasie del SNC o toxoplasmosi); 3. pazienti con anamnesi positiva per neoplasie pregresse (con l'eccezione di: Sarcoma di Kaposi cutaneo senza coinvolgimento viscerale o mucoso risolto con HAART ma senza terapia antiblastica; carcinoma basocellulare della cute sottoposto ad exeresi chirurgica e con margini indenni da neoplasia all'esame istologico); o pregresso trattamento con terapia antiblastica citotossica che possa comportare un aumento del rischio di neoplasia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportions of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL by Ultrasensitive Amplicor HIV-1 Monitor Test, version 1.5) at 48 weeks will be compared to between vicriviroc and control groups as the primary measure of antiviral efficacy. Proportion of subjects with clinically significant laboratory abnormalities (ie, abnormalities requiring medical intervention). |
La proporzione di pazienti che, a 48 settimane presenteranno valori non valutabili di HIV-RNA (< 50 copie/mL misurati con Ultrasensitive Amplicor HIV-1 Monitor Test, versione 1.5). La proporzione di soggetti con anormalita' dei valori di laboratorio clinicamente significativi (es. anormalita' che richiedono un intervento medico). |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
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 | No |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 27 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 27 |
E.8.9.2 | In all countries concerned by the trial days | 0 |