Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Phase 4

Completed

• Conditions: HIV
• Interventions: Drug: Dolutegravir

• Registration Number: NCT02487706
• Lead Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Brief Summary

Data on the capacity of hemodialysis to remove dolutegravir (DTG) from plasma in patients with end-stage renal disease (ESRD) on hemodialysis (HD) are lacking. If DTG was removed from plasma by HD, it would be possible to have subtherapeutic drug concentrations at the end of HD sessions.

Detailed Description

The prevalence of chronic renal disease and end-stage renal disease (ESRD) is increasing in the HIV-positive population. This means that an increasing number of HIV-infected patients will need renal replacement therapy.However, little is known about DTG removal from plasma by HD in patients with ESRD.

Objective: to evaluate the effect of HD on DTG clearance as well as on DTG plasma concentrations at steady state in HIV-infected patients with ESRD undergoing HD.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-29
• Study First Submitted QC: 2015-06-30
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Posted: 2015-07-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion).
2. Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dolutegravir 50mg/day per 5 days	Dolutegravir	Dolutegravir 50mg/day per 5 days

Primary Outcome Measures

Name	Time	Method
hemodialysis extraction ratio of dolutegravir	Day 5
hemodialysis clearance of dolutegravir	Day 5

Secondary Outcome Measures

Name	Time	Method
percentage of patients presenting adverse events related to dolutegravir	From Baseline to day 5

Trial Locations

Locations (1)

Germans Trias i Pujol Hospital; 🇪🇸 Badalona, Barcelona, Spain