HIV
Conditions
Keywords
Hemodialysis, HIV-infection
Brief 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.
Interventions
DRUGDolutegravir
Dolutegravir 50mg/day per 5 days
Sponsors
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hemodialysis extraction ratio of dolutegravir | Day 5 |
| hemodialysis clearance of dolutegravir | Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| percentage of patients presenting adverse events related to dolutegravir | From Baseline to day 5 |
Countries
Spain
Outcome results
None listed