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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Dolutegravir 50mg/day per 5 days

Group Type EXPERIMENTAL

Dolutegravir

Intervention Type DRUG

Dolutegravir 50mg/day per 5 days

Interventions

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Dolutegravir

Dolutegravir 50mg/day per 5 days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No