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

• Sponsor: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02487706
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV	Drug: Dolutegravir	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Removal of Dolutegravir by Hemodialysis in HIV-infected Patients With End-stage Renal Disease
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dolutegravir 50mg/day per 5 days Dolutegravir 50mg/day per 5 days	Drug: Dolutegravir; Dolutegravir 50mg/day per 5 days

Outcome Measures

Primary Outcome Measures

1. hemodialysis extraction ratio of dolutegravir [Day 5]

2. hemodialysis clearance of dolutegravir [Day 5]

Secondary Outcome Measures

1. percentage of patients presenting adverse events related to dolutegravir [From Baseline to day 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Germans Trias i Pujol Hospital	Badalona	Barcelona	Spain	08916

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
• ClinicalTrials.gov Identifier: NCT02487706
• Other Study ID Numbers: DTG_HD
• First Posted: Jul 1, 2015
• Last Update Posted: Oct 1, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia: Hemodialysis; HIV-infection
• Additional relevant MeSH terms: Kidney Failure, Chronic; Dolutegravir

Study Results

No Results Posted as of Oct 1, 2015