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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Fundacio Lluita Contra la SIDA


Information provided by (Responsible Party)
Fundacio Lluita Contra la SIDA
ClinicalTrials.gov Identifier
NCT02487706

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

Purpose

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
HIV

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.

Eligibility

Eligibility

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

Criteria

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

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02487706

Locations

Spain
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  
ClinicalTrials.gov 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:

Hemodialysis
HIV-infection

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Dolutegravir

ClinicalTrials.gov processed this data on October 19, 2017
This information is provided by ClinicalTrials.gov.