Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Patrocinadores

Patrocinador principal: Helen Reynolds

Colaborador: Infectious Disease Institute, Kampala, Uganda
Desmond Tutu HIV Centre

Fuente University of Liverpool
Resumen breve

This is a drug interaction study in HIV negative, TB-monoinfected participants coming to the end of continuation phase of TB therapy, to study the pharmacokinetic changes to dolutegravir when administered with standard, medium and high dose rifampicin.

Estado general Not yet recruiting
Fecha de inicio November 2020
Fecha de Terminación September 2021
Fecha de finalización primaria March 2021
Fase Phase 4
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Change in pharmacokinetic parameter Cmin of dolutegravir Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Resultado secundario
Medida Periodo de tiempo
Change in pharmacokinetic parameter AUC of dolutegravir Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Change in pharmacokinetic parameter Cmax of dolutegravir Day 14, Day 28, Day 42, 5 weeks post anti-tuberculosis treatment
Number of participants with Grade 3 and above adverse events as assessed by DAIDS (corrected v2.1 July 2017) From first dose of dolutegravir until study completion approximately 2 years
Inscripción 36
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Dolutegravir

Descripción: Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin.

Etiqueta de grupo de brazo: Dolutegravir

Elegibilidad

Criterios:

Inclusion Criteria:

- Ability to give informed consent prior to participation

- Willing and able to comply with all study requirements

- Receiving standard doses of RIF and INH

- HIV antibody negative

- Male or non-pregnant, non-breastfeeding female

- Study participation will not extend length of ATT by more than 4 weeks

Exclusion Criteria:

- < 18 years

- Body weight < 50 kg

- eGFR < 60 mL/min

- Abnormal LFTs including ALT > 2.5 ULN

- HIV antibody positive

- Non-standard TB regimen (containing RHZE)

- Women of childbearing age unless using effective contraception

- Family history of sudden cardiac death

- Prior history of cardiac disease that precludes the use of low dose digoxin

- Medical or psychiatric condition that might affect participation in the study based on investigator judgement

- Regular consumption of grapefruit or grapefruit juice

- ECG abnormalities that preclude the use of low dose digoxin (intermittent complete heart block, second degree AV block, supraventricular arrhythmia associated with conducting pathways, ventricular tachycardia or fibrillation)

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Saye Khoo Principal Investigator University of Liverpool
Contacto general

Apellido: Helen Reynolds

Teléfono: +44 151 706 4129

Email: [email protected]

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor-Investigator

Afiliación del investigador: University of Liverpool

Nombre completo del investigador: Helen Reynolds

Título del investigador: Programme manager

Tiene acceso ampliado No
Condición Examinar
Número de brazos 1
Grupo de brazo

Etiqueta: Dolutegravir

Tipo: Experimental

Acrónimo DoRIS
Datos del paciente No
Información de diseño del estudio

Modelo de intervención: Sequential Assignment

Propósito primario: Treatment

Enmascaramiento: None (Open Label)

Fuente: ClinicalTrials.gov