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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 13, 2024

Primary Completion Date

May 7, 2025

Study Completion Date

November 15, 2025

Conditions
HIV-associated Tuberculosis
Interventions
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

Trial Locations (4)

4091

Durban International CRS (Site # 11201), Westridge

6850

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

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

7700

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

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

ViiV Healthcare

INDUSTRY

collaborator

Mylan Inc.

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT05630872 - Pharmacokinetics and Safety of Double-dose Dolutegravir When Used With Rifapentine for HIV-associated Tuberculosis | Biotech Hunter | Biotech Hunter