Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

NCT ID: NCT04166474

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-18
• Study Completion Date: 2024-02-07

Brief 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.

Conditions

Hiv; Tuberculosis

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dolutegravir

Group Type: EXPERIMENTAL

Dolutegravir

Intervention Type: DRUG

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

Interventions

Dolutegravir

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Infectious Disease Institute, Kampala, Uganda

OTHER

Sponsor Role: collaborator

Desmond Tutu HIV Centre

OTHER

Sponsor Role: collaborator

Helen Reynolds

OTHER

Sponsor Role: lead

Responsible Party

Helen Reynolds

Programme manager

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saye Khoo

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

Desmond Tutu Health Foundation

Cape Town, , South Africa

Infectious Diseases Institute

Kampala, , Uganda

Countries

South Africa; Uganda

Other Identifiers

UoL001452

Identifier Type: -

Identifier Source: org_study_id