Clinical Trial Results:
Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease
Summary
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EudraCT number |
2020-004454-30 |
Trial protocol |
ES |
Global end of trial date |
14 Jun 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jul 2022
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First version publication date |
08 Jul 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
DORA-HD
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04689737 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundació de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
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Sponsor organisation address |
S/N Carretera de Canyet, Badalona, Spain, 08916
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Public contact |
FLS-Research Support, Fundació de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència, +34 934657897, jmolto@lluita.org
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Scientific contact |
FLS-Research Support, Fundació de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència, +34 934657897, jmolto@lluita.org
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Jun 2021
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Jun 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the hemodialysis extraction ratio of doravirine in HIV-infected patients with ESRD undergoing intermittent hemodialysis.
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Protection of trial subjects |
not specified
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
04 Jan 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
7
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was done at three major HIV clinics in Catalonia, Spain, in 2021: - Hospital Germans Trias i Pujol, Badalona, Spain - Hospital U. de Bellvitge, Hospitalet de Llobregat, Spain - Hospital U. Vall d’Hebron, Barcelona, Spain | ||||||
Pre-assignment
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Screening details |
Eight participants with HIV infection and ESRD undergoing routine hemodialysis: Males and females* aging ≥ 18 years with Stable antiretroviral treatment for at least 2 weeks before to enrolment and with optimal adherence to antiretroviral treatment (defined as less than 2 missed doses within the previous week) | ||||||
Period 1
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Period 1 title |
Overall period
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Arm 1 | ||||||
Arm description |
Single arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Doravirine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
100mg
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Baseline characteristics reporting groups
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Reporting group title |
Overall period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Arm 1
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Reporting group description |
Single arm |
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End point title |
Doravirine hemodialysis extraction ratio [1] | ||||||||
End point description |
% doravirine in blood samples entering ('Cin') and leaving ('Cout') the dialyzer collected during the dialysis session
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End point type |
Primary
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End point timeframe |
day 6
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No formal statistical comparisons are envisioned. |
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No statistical analyses for this end point |
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End point title |
Doravirine Concentration in plasma at the end of dialysis session | ||||||||
End point description |
ng/mL
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End point type |
Secondary
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End point timeframe |
day 6
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No statistical analyses for this end point |
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End point title |
Ratio of doravirine in plasma | ||||||||
End point description |
Ratio of doravirine concentration in plasma after/before the haemodialysis session
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End point type |
Secondary
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End point timeframe |
day 6
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Day 1 to Day 6
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
single arm
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |