Clinical Trials


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

This study has been completed
Fundacio Lluita Contra la SIDA

Information provided by (Responsible Party)
Fundacio Lluita Contra la SIDA Identifier

First received: June 29, 2015
Last updated: September 30, 2015
Last Verified: September 2015
History of Changes


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.

Condition Intervention Phase

Drug : Dolutegravir
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease

Further study details as provided by Fundacio Lluita Contra la SIDA:

Primary Outcome Measures

  • hemodialysis extraction ratio of dolutegravir [ Time Frame: Day 5 ]
  • hemodialysis clearance of dolutegravir [ Time Frame: Day 5 ]
Secondary Outcome Measures:
  • percentage of patients presenting adverse events related to dolutegravir [ Time Frame: From Baseline to day 5 ]

Enrollment: 5
Study Start Date: June 2015
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Dolutegravir 50mg/day per 5 days
Dolutegravir 50mg/day per 5 days
Drug: Dolutegravir

Dolutegravir 50mg/day per 5 days

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.



Ages Eligible for Study: 18 Years to 99 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria

  1. Age 1 years old or older.
  2. HIV documented infection (western blot)
  3. ESRD undergoing routine hemodialysis
  4. Stable antiretroviral treatment (no changes within the prior 2 weeks)
  5. Signature of informed consent

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.

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT02487706


Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916

Sponsors and Collaborators

Fundacio Lluita Contra la SIDA
More Information

More Information

Responsible Party: Fundacio Lluita Contra la SIDA Identifier: NCT02487706   History of Changes  
Other Study ID Numbers: DTG_HD  
Study First Received: June 29, 2015  
Last Updated: September 30, 2015  

Keywords provided by Fundacio Lluita Contra la SIDA:


Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Dolutegravir processed this data on March 16, 2018
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