NCT05630872

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV-associated Tuberculosis

Interventions

Type	Name	Description
DRUG	Dolutegravir (DTG) 50 mg orally BID (~12 hours apart) plus TDF/3TC	Dolutegravir (DTG) 50 mg orally BID (\~12 hours apart) plus TDF/3TC, from study week 6 until 2 weeks after completion of TB treatment: Morning dose DTG 50 mg QD plus TDF/3TC from study-supplied ARV regimen. Evening dose: DTG 50 mg orally QD from study-supplied source.
DRUG	DTG 50 mg orally QD plus TDF/3TC	DTG 50 mg orally QD plus TDF/3TC from two weeks after completion of TB treatment to end of study (week 48).
DRUG	2HPZM	Daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen
DRUG	2HPM	Daily rifapentine-moxifloxacin plus isoniazid regimen

Timeline

• Start date: 2024-02-13
• Primary completion: 2025-05-07
• Completion: 2025-11-12
• First posted: 2022-11-30
• Last updated: 2025-12-08

Locations

4 sites across 2 countries: South Africa, Thailand

Regulatory

• FDA-regulated drug study