Assesment of dolutegravir removed by hemodialysis in HIV-infected patients with end-stage renal disease.

Removal of dolutegravir by hemodialysis in HIV-infected patients with end-stage renal disease.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000856-16-ES

Enrollment

Registered

2015-04-07

Start date

2015-05-27

Completion date

Unknown

Last updated

2019-12-10

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

Conditions

HIV-infected patients with end-stage renal disease MedDRA version: 17.1 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862 MedDRA version: 17.1 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD) System Organ Class: 100000004857

Interventions

Trade Name: Tivicay Pharmaceutical Form: Tablet INN or Proposed INN: dolutegravir Other descriptive name: DOLUTEGRAVIR Concentration uni

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age 18 years or older Documented HIV-infection ESRD undergoing routine hemodialysis Stable antiretroviral treatment (no changes within the prior 4 weeks) Signature of 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 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Inadequate adhesion to antiretroviral treatment (<90% week previous to inclusion) Suspiction or clinical evidence that the patient will not be able to comply with the study protocol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate hemodialysis extraction ratio and clearance of dolutegravir in HIV-infected patients with end-stage renal disease.;Secondary Objective: To assess safety of dolutegravir in HIV-infected patients with end-stage renal disease.; Primary end point(s): - Hemodialysis extraction ratio of dolutegravir - Hemodialysis clearance of dolutegravir ;Timepoint(s) of evaluation of this end point: Day 5	—

Measure

Time frame

Main Objective: To evaluate hemodialysis extraction ratio and clearance of dolutegravir in HIV-infected patients with end-stage renal disease.;Secondary Objective: To assess safety of dolutegravir in HIV-infected patients with end-stage renal disease.; Primary end point(s): - Hemodialysis extraction ratio of dolutegravir - Hemodialysis clearance of dolutegravir ;Timepoint(s) of evaluation of this end point: Day 5

—

Secondary

Measure	Time frame
Secondary end point(s): Adverse events;Timepoint(s) of evaluation of this end point: From baseline to day 5.	—

Countries

Spain

Contacts

Public ContactUnitat VIH

Fundació Lluita contra la SIDA

rescrig@flsida.org+3493497 84 14

Outcome results

None listed

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