Pharmacokinetics of doravirine following drug intake cessation
Research type
Research Study
Full title
Pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation in healthy volunteers.
IRAS ID
261913
Contact name
Damon Foster
Contact email
Sponsor organisation
Chelsea and Westminster NHS Foundation Trust
Eudract number
2019-000978-33
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 31 days
Research summary
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. Following the last dose regular blood collections will be undertaken for 72 hours to measure how the level of doravirine in blood plasma changes following drug intake cessation (pharmacokinetics). Further to this primary research objective the following analyses will occur:
Data will be collected on the safety and tolerability of doravirine.
Blood, urine and faeces samples will be taken during the study for 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 short term doravirine intake in healthy volunteers.REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/0666
Date of REC Opinion
10 Jun 2019
REC opinion
Further Information Favourable Opinion