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Completed

NCT Number: NCT02487706

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

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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Key information

Conditions

HIV Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Germans Trias i Pujol Hospital

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dolutegravir

Drug

Dolutegravir 50mg/day per 5 days

Primary outcomes

  1. hemodialysis extraction ratio of dolutegravir

    Time frame: Day 5

  2. hemodialysis clearance of dolutegravir

    Time frame: Day 5

Secondary outcomes

  1. percentage of patients presenting adverse events related to dolutegravir

    Time frame: From Baseline to day 5

Sponsors and collaborators

Lead sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 1, 2015
Registry last updated
Oct 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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