E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV infected individuals |
Individuos infectados por el VIH |
|
E.1.1.1 | Medical condition in easily understood language |
HIV infected individuals |
Individuos infectados por el VIH |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. |
- evaluar las concentraciones de Doravirina en el LCR y estimar la penetración en el SNC.
- evaluar la actividad antiviral de una combinación de TAF / FTC + Doravirine en CSF. |
|
E.2.2 | Secondary objectives of the trial |
-To assess Doravirine concentrations in CSF and to estimate penetration into The CNS. - To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. |
- evaluar las concentraciones de Doravirina en el LCR y estimar la penetración en el SNC.
- evaluar la actividad antiviral de una combinación de TAF / FTC + Doravirine en CSF. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age 2. Be on a stable ART continously or ≥3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC+DoravirineC for at least three consecutive months will be eligible. 3. Plasma HIV-1 RNA at screening <40 copies/mL for at least 3 months at the Screening visit. 4. Signed and dated written informed consent prior to inclusion. 5. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study. |
1. Asintomáticos, personas infectadas por VIH-1 ≥ 18 años de edad 2. Estar en tratamiento antirretroviral estable continuamente o ≥3 meses consecutivos antes de la visita de selección. Los pacientes que ya hayan recibido TAF / FTC + DoravirineC durante al menos tres meses consecutivos serán elegibles. 3. ARN de VIH-1 en plasma en la selección <40 copias / ml durante al menos 3 meses en la visita de selección. 4. Consentimiento informado por escrito firmado y fechado antes de la inclusión. 5. Los sujetos deben estar de acuerdo en utilizar un método anticonceptivo altamente efectivo durante las relaciones sexuales heterosexuales de la visita de selección durante toda la duración del estudio. |
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E.4 | Principal exclusion criteria |
1. Severe hepatic impairment (Child-Pugh Class C) 2. Ongoing malignancy 3. Active opportunistic infection 4. Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs. 5. Any verified Grade 4 laboratory abnormality 6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN 7. Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min 8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding. 9. Current treatment with antiaggregant or anticoagulant therapy. 10. History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability. |
1. Insuficiencia hepática grave (clase C de Child-Pugh) 2. malignidad en curso 3. Infección oportunista activa. 4. Resistencia primaria a cualquiera de los ARV incluidos en el estudio o historial de falla virológica con riesgo de selección de resistencia a cualquiera de los fármacos del estudio. 5. Cualquier anormalidad verificada de laboratorio de Grado 4 6. ALT o AST ≥ 3xULN y / o bilirrubina ≥ 1.5xULN 7. Función renal adecuada: tasa de filtración glomerular estimada ≥ 50 ml / min 8. Mujeres embarazadas (según lo confirmado por una prueba de embarazo con suero positiva) o amamantando. 9. Tratamiento actual con antiagregante o terapia anticoagulante. 10. La historia de cualquier enfermedad / condición / tratamiento neurológico puede alterar la permeabilidad de la barrera hematoencefálica. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
-To assess Doravirine concentrations in CSF and to estimate penetration into The CNS.
- To evaluate antiviral activity of a combination of TAF/FTC+Doravirine in CSF. |
- evaluar las concentraciones de Doravirina en el LCR y estimar la penetración en el SNC.
- evaluar la actividad antiviral de una combinación de TAF / FTC + Doravirine en CSF. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
|
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 | No |
E.6.5 | Efficacy | Yes |
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 |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 |
ultima visita ultimo 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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |