Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helen Reynolds
• Collaborators: Desmond Tutu HIV Centre; Infectious Disease Institute, Kampala, Uganda
• Treatments: Dolutegravir; Rifampin

Criteria

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)