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

Phase 1

• 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; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-000856-16-ES
• Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-07
• Study Completion: 2015-07-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.;<br> Primary end point(s): - Hemodialysis extraction ratio of dolutegravir<br> - Hemodialysis clearance of dolutegravir<br> ;Timepoint(s) of evaluation of this end point: Day 5

Secondary Outcome Measures

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