Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT03894124|
Recruitment Status : Completed
First Posted : March 28, 2019
Last Update Posted : August 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus||Drug: Doravirine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single cohort pharmacokinetic (PK) study|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers|
|Actual Study Start Date :||June 12, 2019|
|Actual Primary Completion Date :||July 25, 2019|
|Actual Study Completion Date :||August 6, 2019|
Pifeltro® (doravirine 100mg) daily dose for 7 days
Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
Other Name: Pifeltro
- Steady state plasma concentrations of doravirine after drug intake cessation up to 72 hours post-dose. [ Time Frame: 72 hours from treatment cessation; days 7-10 inclusive from enrolment ]Following cessation of daily doravirine, plasma concentrations of drug to be taken before last dose and at 11 further timepoints over 72 hours.
- Incidence of treatment-emergent adverse events [ Time Frame: From enrolment to last visit; last visit will be between days 20-23 from enrolment ]All adverse events to be recorded and reported during the study up to last visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03894124
|Chelsea and Westminster Hospital NHS Foundation Trust|
|London, United Kingdom, SW10 9NH|
|Principal Investigator:||Marta Boffito||Chelsea and Westminster Hospital NHS Foundation Trust|