Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin (DoRIS)

Helen Reynolds

Status and phase

Completed

Phase 4

Conditions

Tuberculosis

Hiv

Treatments

Drug: Dolutegravir

Study type

Interventional

Funder types

Other

Identifiers

NCT04166474

UoL001452

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)