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

Phase 1

• Conditions: Patients with HIV and end stage renal disease (ESRD) undergoing on intermittent hemodialysis; MedDRA version: 21.1Level: LLTClassification code 10014646Term: End stage renal disease (ESRD)System Organ Class: 100000004857; MedDRA version: 20.1Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004454-30-ES
• Lead Sponsor: Fundació FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-19
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br><br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): •Adverse events grade 3-4 related to doravirine<br>•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