Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease

Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease - DORA-HD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004454-30-ES

Enrollment

Registered

2020-11-19

Start date

2021-01-27

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with HIV and end stage renal disease (ESRD) undergoing on intermittent hemodialysis MedDRA version: 21.1 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 100000004857 MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Pifeltro Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DORAVIRINE Other descriptive name: DORAVIRINE Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Males and females aging = 18 years. 2.Documented HIV infection. 3.Stable antiretroviral treatment for at least 2 weeks prior to enrolment. 4.Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses within the previous week. 5.End-stage renal disease in renal replacement therapy with periodic hemodialysis. 6.Agree with the study procedures and signature of the informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8

Exclusion criteria

Exclusion criteria: 1.Evidence or clinical suspicion that the patient will not be able to comply with the study protocol. 2.Hypersensitivity to doravirine 3.Concomitant therapy within the previous 4 weeks with any of the following drugs: - Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin - Androgen receptor inhibitor: enzalutamide - Antimycobacterials: rifampin, rifapentine - Cytotoxic agent: mitotane - St. John’s wort (Hypericum perforatum) 4.Females who are pregnant or breastfeeding. 5.ALT and/ or AST = 4 times the upper limit of normal (ULN) at screening. 6.Hemoglobin < 7,5 g/dL at screening.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the hemodialysis extraction ratio of doravirine in HIV-infected patients with ESRD undergoing intermittent hemodialysis.;Secondary Objective: To evaluate the safety of doravirine un HIV-infected participants with ESRD on hemodialysis To evaluate the effect of a hemodialysis session on doravirine concentrations in plasma in HIV-infected participants with ESRD;Primary end point(s): - To calculate the hemodialysis extraction ratio for doravirine in HIV-infected participants with ESRD;Timepoint(s) of evaluation of this end point: Day 6	—

Measure

Time frame

Main Objective: To assess the hemodialysis extraction ratio of doravirine in HIV-infected patients with ESRD undergoing intermittent hemodialysis.;Secondary Objective: To evaluate the safety of doravirine un HIV-infected participants with ESRD on hemodialysis To evaluate the effect of a hemodialysis session on doravirine concentrations in plasma in HIV-infected participants with ESRD;Primary end point(s): - To calculate the hemodialysis extraction ratio for doravirine in HIV-infected participants with ESRD;Timepoint(s) of evaluation of this end point: Day 6

—

Secondary

Measure	Time frame
Secondary end point(s): • Adverse events grade 3-4 related to doravirine • Doravirine concentrations in plasma at the beginning and at the end of a dialysis session;Timepoint(s) of evaluation of this end point: - Day 6	—

Countries

Spain

Contacts

Public ContactFLS-Research Support

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

cherrero@flsida.org+34934978414

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026