E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with HIV and end stage renal disease (ESRD) undergoing on intermittent hemodialysis |
Pacientes con VIH y insuficiencia renal crónica terminal sometidos a sesiones intermitentes de hemodiálisis |
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E.1.1.1 | Medical condition in easily understood language |
Patients with HIV and end stage renal disease undergoing on intermittent hemodialysis |
Pacientes con VIH y insuficiencia renal crónica terminal sometidos a hemodiálisis |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014646 |
E.1.2 | Term | End stage renal disease (ESRD) |
E.1.2 | System Organ Class | 100000004857 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
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 assess the hemodialysis extraction ratio of doravirine in HIV-infected patients with ESRD undergoing intermittent hemodialysis. |
Calcular el coeficiente de extracción de doravirina mediante hemodiálisis en participantes VIH con IRC terminal. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the safety of doravirine un HIV-infected participants with ESRD on hemodialysis
To evaluate the effect of a hemodialysis session on doravirine concentrations in plasma in HIV-infected participants with ESRD |
- Evaluar la seguridad (eventos adversos grado 3-4) de doravirina en participantes VIH con insuficiencia renal crónica terminal sometidos a hemodiálisis.
- Evaluar los cambios en las concentraciones plasmáticas de doravirina durante una sesión de hemodiálisis en participantes VIH con insuficiencia renal crónica terminal |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Males and females aging ≥ 18 years. 2.Documented HIV infection. 3.Stable antiretroviral treatment for at least 2 weeks prior to enrolment. 4.Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses within the previous week. 5.End-stage renal disease in renal replacement therapy with periodic hemodialysis. 6.Agree with the study procedures and signature of the informed consent. |
1. Hombres y mujeres edad ≥ 18 años. 2. Infección documentada por VIH 3. Tratamiento antirretroviral estable durante al menos 2 semanas antes de la inclusión en el estudio. 4. Adherencia óptima al tratamiento antirretroviral, definida como menos de 2 dosis olvidadas durante la semana anterior a la inclusión en el estudio. 5. Insuficiencia renal crónica terminal en tratamiento renal sustitutivo con hemodiálisis periódica. 6. Aceptar los procedimientos del estudio y la firma del consentimiento informado. |
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E.4 | Principal exclusion criteria |
1.Evidence or clinical suspicion that the patient will not be able to comply with the study protocol. 2.Hypersensitivity to doravirine 3.Concomitant therapy within the previous 4 weeks with any of the following drugs: - Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin - Androgen receptor inhibitor: enzalutamide - Antimycobacterials: rifampin, rifapentine - Cytotoxic agent: mitotane - St. John’s wort (Hypericum perforatum) 4.Females who are pregnant or breastfeeding. 5.ALT and/ or AST ≥ 4 times the upper limit of normal (ULN) at screening. 6.Hemoglobin < 7,5 g/dL at screening. |
1.Evidencia o sospecha clínica de que el paciente no podrá cumplir con el protocolo del estudio. 2.Hipersensibilidad a la doravirina 3.Tratamiento concomitante durante las 4 semanas previas a la inclusión con cualquiera de los siguientes tratamientos: - Anticonvulsivos: carbamazepina, oxcarbazepina, fenobarbital, fenitoína - Antiandrógenos: enzalutamida - Antimicrobianos: rifampicina, rifapentina - Agente citotóxico: mitotano - Hierba de San Juan (Hypericum perforatum) 4.Mujeres embarazadas o en período de lactancia. 5.ALT y / o AST ≥ 4 veces el límite superior de normalidad (LSN) en el screening. 6.Hemoglobina <7,5 g / dL en el screening |
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E.5 End points |
E.5.1 | Primary end point(s) |
- To calculate the hemodialysis extraction ratio for doravirine in HIV-infected participants with ESRD |
Calcular la tasa de extracción de hemodiálisis de doravirina en participantes con VIH e insuficiencia renal crónica terminal |
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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) |
• Adverse events grade 3-4 related to doravirine • Doravirine concentrations in plasma at the beginning and at the end of a dialysis session |
- Eventos adversos de grado 3-4 relacionados con la doravirina
- Concentraciones de doravirina en plasma al inicio y final de la sesión de diálisis |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
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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LVLS |
Ultima visita último paciente |
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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 | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |