Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

UoL001452

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.

2021-11-18

2024-01-01

2024-04-01

Active (not recruiting)

Early phase I

36

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)

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ACTUAL'}}

2023-11-13