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

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

Status and phase

Completed

Phase 4

Conditions

HIV

Treatments

Drug: Dolutegravir

Study type

Interventional

Funder types

Other

Identifiers

NCT02487706

DTG_HD

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.