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Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

NCT04166474•Helen Reynolds

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+2 more criteria

Locations (2)

Desmond Tutu Health Foundation

Cape Town, South Africa

Infectious Diseases Institute

Kampala, Uganda

Key Dates

Start Date

November 18, 2021

Primary Completion Date

February 7, 2024

Completion Date

February 7, 2024

Last Updated

August 13, 2024

Enrollment

ACTUAL participants

Conditions

HivTuberculosis

Interventions

Dolutegravir

DRUG

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HIV Positive

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Drug Interactions Between Dolutegravir and Escalating Doses of Rifampicin

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

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