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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacio Lluita Contra la SIDA; Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• Treatments: Dolutegravir

Criteria

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.