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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02487706
• Other study ID #: DTG_HD
• Status: Completed
• Phase: Phase 4
• First received: June 29, 2015
• Last updated: September 30, 2015
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: September 2015
• Source: Fundacio Lluita Contra la SIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• HIV
• Kidney Failure, Chronic

Intervention

Drug:
• Dolutegravir
Dolutegravir 50mg/day per 5 days

Locations

Country	Name	City	State
Spain	Germans Trias i Pujol Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio Lluita Contra la SIDA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemodialysis extraction ratio of dolutegravir		Day 5	No
Primary	hemodialysis clearance of dolutegravir		Day 5	No
Secondary	percentage of patients presenting adverse events related to dolutegravir		From Baseline to day 5	Yes