NCT03894124

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Chelsea and Westminster NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers

Detailed description

The administration of combination antiretroviral therapy (cART) to HIV-infected patients has been associated with a dramatic reduction in AIDS-related morbidity and mortality. The key to successful HIV drug treatment is adhering to the prescribed combination every day. The approval of single tablet combinations (STRs) provides HIV care providers with a "one tablet once a day" therapy, making adherence much easier for patients. However, in HIV therapy, successful adherence also means attention to intervals between doses or dietary restrictions. Ideally, to guarantee long-term virological response, HIV-infected patients should take their cART every day at the same time. However, cART is for life and doses can be forgotten or delayed. For this study 14 healthy volunteers will receive Pifeltro® (doravirine 100mg tablets) daily for 7 days to reach steady state. Following the last dose samples will be taken for pharmacokinetic testing over 72 hours. The incidence of adverse events between enrolment to the study (day 1) and last visit (day 20-23) will be recorded. Blood, urine and faecal samples from study subjects will be taken for use in planned exploratory research and for use in future research: Analyses looking at genes which affect drug disposition (pharmacogenomics); the impact of doravirine intake on platelet function and markers of platelet and endothelial cell activation; metabolic changes associated with doravirine.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Doravirine	Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.

Timeline

• Start date: 2019-06-12
• Primary completion: 2019-07-25
• Completion: 2019-08-06
• First posted: 2019-03-28
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United Kingdom