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

Primary Purpose

HIV

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Dolutegravir
Sponsored by
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV focused on measuring Hemodialysis, HIV-infection

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Germans Trias i Pujol Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dolutegravir 50mg/day per 5 days

Arm Description

Dolutegravir 50mg/day per 5 days

Outcomes

Primary Outcome Measures

hemodialysis extraction ratio of dolutegravir
hemodialysis clearance of dolutegravir

Secondary Outcome Measures

percentage of patients presenting adverse events related to dolutegravir

Full Information

First Posted
June 29, 2015
Last Updated
September 30, 2015
Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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1. Study Identification

Unique Protocol Identification Number
NCT02487706
Brief Title
Assessment of Dolutegravir Removed by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Official Title
Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV
Keywords
Hemodialysis, HIV-infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dolutegravir 50mg/day per 5 days
Arm Type
Experimental
Arm Description
Dolutegravir 50mg/day per 5 days
Intervention Type
Drug
Intervention Name(s)
Dolutegravir
Intervention Description
Dolutegravir 50mg/day per 5 days
Primary Outcome Measure Information:
Title
hemodialysis extraction ratio of dolutegravir
Time Frame
Day 5
Title
hemodialysis clearance of dolutegravir
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
percentage of patients presenting adverse events related to dolutegravir
Time Frame
From Baseline to day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Age 1 years old or older. HIV documented infection (western blot) ESRD undergoing routine hemodialysis Stable antiretroviral treatment (no changes within the prior 2 weeks) Signature of informed consent Exclusion Criteria: Inadequate adherence to antiretroviral treatment (<90% in the week prior to inclusion). Clinical evidence or suspicion that the patient will not be able to comply with the study protocol.
Facility Information:
Facility Name
Germans Trias i Pujol Hospital
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26856824
Citation
Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.
Results Reference
derived

Learn more about this trial

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

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