This study will evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.
The purpose of this study is to evaluate the potential drug-drug interactions between dolutegravir (DTG) and steady state rifapentine (RPT) when RPT is given with isoniazid (INH) daily for 4 weeks (1HP) as part of treatment for latent TB infection (LTBI) in HIV-1 and LTBI co-infected individuals.
Participants will receive study-provided INH and RPT once daily for 4 weeks (1HP). During the 1HP treatment, DTG will be administered twice daily in Arm 1, and once daily in Arm 2.
At study entry, all participants must also be on DTG-based antiretroviral (ARV) treatment with 2 nucleoside reverse transcriptase inhibitors (NRTIs) (excluding tenofovir alafenamide [TAF]) during the study. In Arm 1 participants, DTG 50 mg will be administered twice daily; the morning dose from non-study ARV supply and the evening dose from study supply. In Arm 2 participants, DTG 50 mg will be administered once daily, in the morning, from non-study ARV supply.
Participants must receive pyridoxine (vitamin B6) with each dose of INH based on the current local, national, or international dosing guidelines. NRTI therapy and pyridoxine (vitamin B6) will not be provided by the study.
The study will begin enrollment with Arm 1. Opening of Arm 2 will depend on assessment of DTG pharmacokinetics (PK) data from participants in Arm 1.
The majority of participants will be on study for 6 weeks (a 4-week on-study treatment period and a 2-week follow-up period). Some participants may be on study for up to 11 weeks if the on-study treatment duration has been extended or if participants need to have additional follow-up visits to measure viral load.
| Condition | HIV Infection, LTBI |
|---|---|
| Treatment | Dolutegravir (DTG), Isoniazid (INH), Rifapentine (RPT), Pyridoxine (vitamin B6), Antiretroviral Therapy (ART) |
| Clinical Study Identifier | NCT04272242 |
| Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
| Last Modified on | 20 July 2022 |
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