Human Immunodeficiency Virus Clinical Trial
Official title:
A Phase 1, Open-Label, Fixed-Sequence, Drug Interaction Study to Investigate the Effect of Once-Weekly Rifapentine and Isoniazid on the Pharmacokinetics of Steady-State Doravirine
Drug therapy for persons living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) co-infected with latent tuberculosis infection (LTBI) is complex. Anti-tuberculosis drugs used to treat LTBI often induce drug metabolizing enzymes that share the same metabolic pathway as antiretroviral drugs used for those living with HIV/AIDS. This study evaluates the drug-drug interaction (DDI) potential of an antiretroviral drug when co-administered with a common anti-tuberculosis regimen of drugs.
Rifapentine (RPT) and isoniazid (INH) given once weekly for 12 weeks is commonly used for
treating LTBI in adults. For people living with HIV-1, the risks of LTBI is increased.
Individuals living with HIV-1 are often on chronic antiretroviral drugs that prevent
immunodeficiency and complications associated with infection. Unfortunately, antiretroviral
drugs are subject to many DDIs especially with RPT which induces drug clearing enzymes.
Doravirine (DOR) is a newly approved non-nucleoside reverse transcriptase inhibitor indicated
for the treatment of HIV-1 infection. Because RPT induces the metabolic pathway in which DOR
is removed, there is concern that taking both concomitantly will result in an unwanted DDI
leading to reduced DOR concentrations in the blood. Reduced levels will result in loss of
efficacy for the drug and therefore not provide adequate viral suppression in those living
with HIV. This study investigates the DDI potential of the once weekly regimen RPT and INH
together with DOR in healthy volunteers.
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