Assessment of Dolutegravir Removed by Hemodialysis in HIV... | NCT02487706

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

NCT02487706

Sponsor

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

Status

Completed

Last Update Posted

Oct 1, 2015Estimated

Enrollment

5Actual

Phase

Phase 4

Conditions

Interventions

Dolutegravir

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

Jun 29, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 30, 2015

Last Update Posted Date

Oct 1, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dolutegravir 50mg/day per 5 days	Experimental	Dolutegravir 50mg/day per 5 days	Drug: Dolutegravir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dolutegravir	Drug	Dolutegravir 50mg/day per 5 days	Dolutegravir 50mg/day per 5 days

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hemodialysis extraction ratio of dolutegravir		Day 5
hemodialysis clearance of dolutegravir		Day 5

Secondary Outcomes

Measure	Description	Time Frame
percentage of patients presenting adverse events related to dolutegravir		From Baseline to day 5

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Germans Trias i Pujol Hospital		Badalona	Barcelona	08916	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26856824	Derived	Molto J, Graterol F, Miranda C, Khoo S, Bancu I, Amara A, Bonjoch A, Clotet B. Removal of Dolutegravir by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease. Antimicrob Agents Chemother. 2016 Mar 25;60(4):2564-6. doi: 10.1128/AAC.03131-15. Print 2016 Apr.

ID	Term
D015658	HIV Infections
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections