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
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
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
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.
Primary Immunodeficiency Disorders,
human immunodeficiency virus,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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