| Trial ID: | L1495 |
| Source ID: | NCT04689737
|
| Associated Drug: |
Doravirine
|
| Title: |
Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT04689737/results
|
| Conditions: |
HIV-infected Participants With ESRD Undergoing Routine Hemodialysis
|
| Interventions: |
DRUG: Doravirine
|
| Outcome Measures: |
Primary: Percentatge of Doravirine Dialysis Extraction Ratio (ER), 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., At day 6 | Secondary: Percentage of Participants Developing Related Adverse Events Grade 3-4 Related to Doravirine, 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., Baseline to day 20|Doravirine Concentration (mg/dl), Doravirine Concentration (mg/dl) in plasma at the end of the haemodialysis session., At day 6
|
| Sponsor/Collaborators: |
Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | Collaborators: Merck Sharp & Dohme LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
8
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2021-03-20
|
| Completion Date: |
2021-06-14
|
| Results First Posted: |
2024-08-27
|
| Last Update Posted: |
2024-08-27
|
| Locations: |
Germans Trias i Pujol Hospital, Badalona, Barcelona, 08916, Spain|Universitario Bellvitge Hospital, Hospitalet de Llobregat, Barcelona, 08907, Spain|Valle Hebron Hospital, Barcelona, 08035, Spain
|
| URL: |
https://clinicaltrials.gov/show/NCT04689737
|
