E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-infected patients on stable treatment with darunavir / ritonavir 800/100 mg qd plus two transcriptase inhibitors, nucleoside analogs for at least 4 weeks. |
Pacientes infectados por el VIH en tratamiento estable con darunavir/ritonavir 800/100 mg qd más dos inhibidores de la transcriptasa análogos de los nucleósidos durante al menos 4 semanas. |
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E.1.1.1 | Medical condition in easily understood language |
HIV-infected patients on stable therapy with Prezista / Norvir plus two nucleoside analogs for at least 4 weeks. |
Pacientes infectados por el VIH en tratamiento estable con Prezista/Norvir más dos análogos de nucleósidos durante al menos 4 semanas. |
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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 | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 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 |
Compare the proportion of patients maintaining HIV viral load in plasma <50 copies / mL after 48 weeks of follow-up. |
Comparar la proporción de pacientes que mantienen la carga viral del VIH en plasma <50 copias/mL tras 48 semanas de seguimiento. |
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E.2.2 | Secondary objectives of the trial |
1. Compare the proportion of patients maintaining HIV viral load in plasma <50 copies / mL 2. Compare changes in CD4 lymphocyte count 3.Compare the incidence of adverse events 4. Compare changes in lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) 5. Compare changes in liver enzymes (AST, ALT, AF, GGT) 6. Evaluate the economic impact (direct costs associated with the dispensing of antiretroviral medications, medical visits and complementary explorations) 7. Compare the proportion of patients that maintains a DRV trough concentration> 55 ng / mL 8.The patients who fail, to evaluate the incidence of new resistance mutations to antiretroviral drugs. |
1.Comparar la proporción de pacientes que mantienen la carga viral del VIH en plasma <50 copias/mL 2.Comparar los cambios en el recuento de linfocitos CD4 3.Comparar la incidencia de los acontecimiento adversos 4.Comparar los cambios en el perfil lipídico (colesterol total, HDL-colesterol, LDL-colesterol, triglicéridos) 5.Comparar los cambios en los enzimas hepáticos (AST, ALT, FA, GGT) 6.Evaluar el impacto económico (costes directos derivados de la dispensación de la medicación antirretroviral, visitas médicas y exploraciones complementarias) 7.Comparar la proporción de pacientes que mantiene una concentración valle de DRV >55 ng/mL 8.En los pacientes que fracasen, evaluar la incidencia de nuevas mutaciones de resistencia a los antirretrovirales. |
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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 |
Pharmacokinetic substudy in 15 patients of each study arm. Objective: To compare the pharmacokinetic parameters (Cmax, Cmin, AUC0-24) of darunavir when administered at doses of 800 or 600 mg qd plus 100 mg ritonavir |
Subestudio farmacocinético en 15 pacientes de cada rama del estudio. Objetivo: comparar los parámetros farmacocinéticos (Cmax, Cmin, AUC0-24) de darunavir cuando se administra a dosis de 800 ó 600 mg qd más 100 mg de ritonavir |
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E.3 | Principal inclusion criteria |
- Treatment stable with darunavir / ritonavir 800/100 mg qd plus two nucleoside analogs transcriptase inhibitors for at least 4 weeks. - HIV viral load in plasma <50 copies / mL for at least 12 weeks. |
- Tratamiento estable con darunavir/ritonavir 800/100 mg qd más dos inhibidores de la transcriptasa análogos de los nucleósidos durante al menos 4 semanas. - Carga viral del VIH en plasma <50 copias/mL durante al menos 12 semanas. |
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E.4 | Principal exclusion criteria |
- AIDS-defining disease in the previous 4 weeks. -Virologic failure history previous antiretroviral treatment regimens that included protease inhibitor drugs. - Presence of darunavir resistance mutations documented in previous genotypes. |
- Enfermedad definitoria de SIDA en las 4 semanas previas. - Historia de fracaso virológico previo esquemas de tratamiento antirretroviral que incluyeran fármacos inhibidores de la proteasa. - Presencia de mutaciones de resistencia a darunavir documentadas en genotipos previos. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Compare the proportion of patients maintaining HIV viral load in plasma <50 copies / mL after 48 weeks of follow-up. |
Comparar la proporción de pacientes que mantienen la carga viral del VIH en plasma <50 copias/mL tras 48 semanas de seguimiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Compare the proportion of patients maintaining HIV viral load in plasma <50 copies / mL after 4, 12, 24 and 36 weeks follow up. 2. Compare changes in CD4 lymphocyte count after 12, 24,36 and 48 weeks follow up. 3.Compare the incidence of adverse events after 4, 12, 24, 36 and 48 weeks follow up. 4. Compare changes in lipid profile (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) after 4, 12, 24, 36 and 48 weeks follow up.
5. Compare changes in liver enzymes (AST, ALT, AF, GGT) after 4, 12, 24, 36 and 48 weeks follow up.
6. Evaluate the economic impact (direct costs associated with the dispensing of antiretroviral medications, medical visits and complementary explorations) 7. Compare the proportion of patients that maintains a DRV trough concentration> 55 ng / mL after 4, 12, 24, 36 and 48 weeks follow up.
8.The patients who fail, to evaluate the incidence of new resistance mutations to antiretroviral drugs. |
1. Comparar la proporción de pacientes que mantienen la carga viral del VIH en plasma <50 copias/mL tras 4, 12, 24 y 36 semanas de seguimiento.
2. Comparar los cambios en el recuento de linfocitos CD4 tras 12, 24, 36 y 48 semanas de seguimiento.
3. Comparar la incidencia de los acontecimiento adversos tras 4, 12, 24, 36 y 48 semanas de seguimiento.
4. Comparar los cambios en el perfil lipídico (colesterol total, HDL-colesterol, LDL-colesterol, triglicéridos) tras 4, 12, 24, 36 y 48 semanas de seguimiento.
5. Comparar los cambios en los enzimas hepáticos (AST, ALT, FA, GGT) tras 4, 12, 24, 36 y 48 semanas de seguimiento.
6. Evaluar el impacto económico (costes directos derivados de la dispensación de la medicación antirretroviral, visitas médicas y exploraciones complementarias) de reducir la dosis de darunavir/ritonavir a 600/100mg qd.
7. Comparar la proporción de pacientes que mantiene una concentración valle de DRV >55 ng/mL tras 4, 12, 24, 36 y 48 semanas de seguimiento.
8. Comparar los parámetros farmacocinéticos (Cmax, Cmin, AUC0-24) de darunavir cuando se administra a dosis de 800 ó 600 mg qd más 100 mg de ritonavir (subestudio farmacocinético).
9. En los pacientes que fracasen, evaluar la incidencia de nuevas mutaciones de resistencia a los antirretrovirales. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
4, 12, 24, 36 and 48 weeks |
4, 12, 24, 36 y 48 semanas |
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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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
800 mg Prezista QD |
800 mg Prezista QD |
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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 | 4 |
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 | No |
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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Last visit of last patient included |
Última visita del último paciente incluido |
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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 | 9 |
E.8.9.1 | In the Member State concerned days | 0 |