NCT02487706

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Dolutegravir	Dolutegravir 50mg/day per 5 days

Timeline

• Start date: 2015-06-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-07-01
• Last updated: 2015-10-01

Locations

1 site across 1 country: Spain