Doravirine Concentrations and Antiviral Activity in Cerebrospinal Fluid in HIV-1 Infected Individuals
Status:
Not yet recruiting
Trial end date:
2020-10-01
Target enrollment:
Participant gender:
Summary
Doravirine is a new HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) that has
demonstrated a good efficacy and safety profile in clinical trials. It functions by
inhibiting viral replication of both wild-type virus and most common NNRTI variants. It is
dosed orally once daily and always given in combination with other HIV-1 active agents as
part of highly active antiretroviral therapy. Initial pharmacokinetic studies demonstrated
not extensive binding to plasma proteins, which may be crucial determinant for penetration to
different reservoirs such as the central nervous system (CNS). This study will address two
important issues: The pharmacokinetic profile of Doravirine in cerebrospinal fluid (CSF) as
well as the maintenance of HIV suppression in CSF. The assessment of concentrations as well
as the antiviral activity of new antiretroviral drugs in compartments such as CNS is relevant
to avoid HIV-related neurocognitive disorders as well as for future cure strategies. In
addition, the role of unbound ARV drug concentrations has been scarcely evaluated.
Phase:
Phase 3
Details
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia Hospital Universitari de Bellvitge
Collaborators:
Fundacio Lluita Contra la SIDA Hospital Universitari de Bellvitge Institut d'Investigació Biomèdica de Bellvitge