E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-infected patients with end-stage renal disease |
PACIENTES INFECTADOS POR EL VIH CON INSUFICIENCIA RENAL CRÓNICA TERMINAL |
|
E.1.1.1 | Medical condition in easily understood language |
HIV-infected patients with end-stage renal disease |
PACIENTES INFECTADOS POR EL VIH CON INSUFICIENCIA RENAL CRÓNICA TERMINAL |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
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 |
|
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 evaluate hemodialysis extraction ratio and clearance of dolutegravir in HIV-infected patients with end-stage renal disease. |
Evaluar la tasa de extracción y el aclaramiento de dolutegravir por la hemodiálisis en los pacientes infectados por el VIH con insuficiencia renal crónica terminal. |
|
E.2.2 | Secondary objectives of the trial |
To assess safety of dolutegravir in HIV-infected patients with end-stage renal disease. |
Evaluar la seguridad de dolutegravir en los pacientes infectados por el VIH con insuficiencia renal crónica terminal. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age 18 years or older Documented HIV-infection ESRD undergoing routine hemodialysis Stable antiretroviral treatment (no changes within the prior 4 weeks) Signature of informed consent. |
Edad igual o superior a 18 años. Infección por VIH documentada Insuficiencia renal crónica terminal en tratamiento renal sustitutivo con hemodiálisis periódicas. Tratamiento antirretroviral estable durante al menos 2 semanas previas a la inclusión. Firma del consentimiento informado. |
|
E.4 | Principal exclusion criteria |
Inadequate adhesion to antiretroviral treatment (<90% week previous to inclusion) Suspiction or clinical evidence that the patient will not be able to comply with the study protocol. |
Adherencia inadecuada al tratamiento antirretroviral (<90% en la semana previa a la inclusión). Evidencia o sospecha clínica de que el paciente no será capaz de cumplir con el protocolo del estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Hemodialysis extraction ratio of dolutegravir - Hemodialysis clearance of dolutegravir |
Tasa de extracción por la hemodiálisis de dolutegravir Aclaramiento por la hemodiálisis de dolutegravir |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Adverse events |
Acontecimientos adversos |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
From baseline to day 5. |
Desde basal a día 5 |
|
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 | No |
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 | No |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
LVLS |
Última visita del último paciente. |
|
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 | 1 |
E.8.9.1 | In the Member State concerned days | |