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Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

NCT04166474 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-08-13

No results posted yet for this study

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

Interventions

DRUG

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.

Sponsors & Collaborators

  • Infectious Disease Institute, Kampala, Uganda

    collaborator OTHER

  • Desmond Tutu HIV Centre

    collaborator OTHER

  • Helen Reynolds

    lead OTHER

Principal Investigators

  • Saye Khoo · University of Liverpool

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-18
Primary Completion
2024-02-07
Completion
2024-02-07

Countries

  • South Africa
  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04166474 on ClinicalTrials.gov