Trial Outcomes & Findings for Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD) (NCT NCT04689737)

Results Overview

The haemodialysis extraction ratio (ER) for doravirine was calculated as: ER(%) = ((Cin - Cout)/ Cin) × 100 where Cin is the pre-dialyser doravirine concentration (i.e. blood entering the dialyser) and Cout is the post-dialyser doravirine concentration (i.e. blood leaving the dialyser). Post-dialyser doravirine concentrations (Cout) were corrected for haemoconcentration by a factor F based on total protein (TP) concentration pre- and post-dialyser: F = TPin / TPout.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

8 participants

Primary outcome timeframe

At day 6

Results posted on

2024-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Group Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Group n=8 Participants Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=8 Participants
Age, Categorical >=65 years	1 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=8 Participants
Sex: Female, Male Male	6 Participants n=8 Participants
Region of Enrollment Spain	8 participants n=8 Participants

PRIMARY outcome

Timeframe: At day 6

The haemodialysis extraction ratio (ER) for doravirine was calculated as: ER(%) = ((Cin - Cout)/ Cin) × 100 where Cin is the pre-dialyser doravirine concentration (i.e. blood entering the dialyser) and Cout is the post-dialyser doravirine concentration (i.e. blood leaving the dialyser). Post-dialyser doravirine concentrations (Cout) were corrected for haemoconcentration by a factor F based on total protein (TP) concentration pre- and post-dialyser: F = TPin / TPout.

Outcome measures

Outcome measures
Measure	Experimental Group n=8 Participants Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Percentatge of Doravirine Dialysis Extraction Ratio (ER)	34.3 percentage of doravirine dialysis ER Interval 25.8 to 41.4

SECONDARY outcome

Timeframe: Baseline to day 20

Percentage of participants developing related adverse events grade 3 or grade 4 related to doravirine. Defining Grade 3 (severe) as symptoms causing inability to perform usual social and functional activities and Grade 4 (potentially life-threatening)as Symptoms causing inability to perform basic self-care functions or Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.

Outcome measures

Outcome measures
Measure	Experimental Group n=8 Participants Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Percentage of Participants Developing Related Adverse Events Grade 3-4 Related to Doravirine	2 Participants

SECONDARY outcome

Timeframe: At day 6

Doravirine Concentration (mg/dl) in plasma at the end of the haemodialysis session.

Outcome measures

Outcome measures
Measure	Experimental Group n=8 Participants Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Doravirine Concentration (mg/dl)	785 mg/dl Interval 101.0 to 1851.0

Adverse Events

Experimental Group

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Group n=8 participants at risk Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
Surgical and medical procedures IQ-RCFI EM Hospitalization for Fibula Fracture	12.5% 1/8 • Number of events 1 • Day 1 to Day 20
Cardiac disorders Cardiac insufficiency	12.5% 1/8 • Number of events 1 • Day 1 to Day 20

Other adverse events

Other adverse events
Measure	Experimental Group n=8 participants at risk Doravirine (Pifeltro, MSD) will be added to participant's cART (100 mg once daily) for 5 days Doravirine: Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
General disorders Headache	12.5% 1/8 • Number of events 1 • Day 1 to Day 20
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • Day 1 to Day 20

Additional Information

Dr. Jose Molto Marhuenda

Fundació de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència

Phone: +34 934657897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place