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Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis | Clinical Trials | Clareo Health

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Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis

NCT05630872•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

A5406 hypothesizes that dolutegravir (DTG) 50 mg taken twice daily will provide adequate exposures to maintain viral suppression when dosed with rifapentine (RPT) 1200 mg for HIV-associated TB.

Detailed Description

This is an open-label, single arm, phase II, multicenter PK study to investigate the effect of daily RPT 1200 mg on DTG exposure in participants with HIV-associated TB. Adults with HIV with newly diagnosed DS-TB who are not currently on ART will be recruited around the time of DS TB diagnosis. At study entry, the 2HPZM/2HPM regimen will be initiated for anti-tuberculosis (anti-TB) therapy and continued for 17 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Individuals ≥18 years of age at study entry.
•2. Weight ≥40 kg.
•3. Body mass index (BMI) \>18.5 kg/m2.
•4. Ability and willingness of participant or legal guardian/representative to provide informed consent.
•5. Documentation of HIV-1 status.
•6. CD4+ cell count ≥100 cells/mm3 obtained within 30 days prior to study entry at any network-approved non-US laboratory that is IQA certified.
•7. ART-naïve or not on ART for 12 consecutive weeks prior to TB diagnosis.
•8. Willingness and eligibility to start DTG-based ART at 6 weeks, with a window of ±1 week, after starting TB treatment, with no intention to change ART for the duration of the study.
•9. Documentation of pulmonary TB.
•10. Willingness to start 2HPZM/2HPM therapy for DS-TB.
+11 more criteria

Exclusion Criteria

•1. Breastfeeding, pregnant, or plans to become pregnant.
•2. Known allergy/sensitivity or any hypersensitivity to components of the study drugs, or their formulations.
•3. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
•4. Requirement for ongoing use of drugs that are known to have significant drug-drug interactions with DTG or RPT.
•5. Known history of acute intermittent porphyria.
•6. Previous treatment for active TB disease.
•7. More than 5 days of treatment directed against active TB for the current TB episode preceding study entry.
•8. At the time of study entry, documentation of an M. tuberculosis isolate from the current or previous treatment episode known to be resistant to RIF or INH.
•9. Known history of prolonged QT syndrome.
•10. Known cirrhosis, a history of decompensated liver disease (ascites, hepatic encephalopathy, or esophageal varices).
+3 more criteria

Locations (4)

University of Cape Town Lung Institute (UCTLI) CRS (Site # 31792)

Mowbray, Cape Town, Western Cape, South Africa

Durban International CRS (Site # 11201)

Westridge, Durban RSA, South Africa

South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site # 31793)

Worcester, Western Province, South Africa

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site # 31802)

Bangkok, Thailand

Key Dates

Start Date

February 13, 2024

Primary Completion Date

May 7, 2025

Completion Date

November 12, 2025

Last Updated

December 8, 2025

Enrollment

ACTUAL participants

Conditions

HIV-associated Tuberculosis

Interventions

Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC

DRUG

DTG 50 mg orally QD plus TDF/3TC

DRUG

2HPZM

DRUG

2HPM

DRUG