Clinical Trial Results:
Pharmacokinetics, safety and efficacy of atazanavir /dolutegravir/lamivudine regimen as maintenance regimen in pa-tients with intolerance and/or resistance to NRTIs, NNRTIs and RTV: a pilot study (PRADA II study)
Summary
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EudraCT number |
2014-004488-19 |
Trial protocol |
NL |
Global end of trial date |
27 Dec 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Sep 2019
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First version publication date |
21 Sep 2019
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Other versions |
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Summary report(s) |
PRADA abstract P31 |
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 |
UMCN-AKF-14.08
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Radboudumc
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Sponsor organisation address |
Geert Grooteplein Zuid 10, Nijmegen, Netherlands,
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Public contact |
David Burger, Radboud University Medical Center, +31 243616405, david.burger@radboudumc.nl
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Scientific contact |
David Burger, Radboud University Medical Center, +31 243616405, david.burger@radboudumc.nl
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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 |
27 Sep 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
27 Dec 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
27 Dec 2016
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To assess the pharmacokinetics of the alternative maintenance QD regimen combining atazanavir, dolutegravir and lamivudine in HIV infected patients.
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Protection of trial subjects |
The risk-classification is assessed as ‘moderate’ to the patient population receiving study drug at the current regimen. The drugs are licensed on the Dutch market for the dose administered. Atazanavir 400 mg once daily with food is licensed in de US. The study participants are HIV-1 infected patients who experience side-effects or intolerance to their current regimen. Switching to a new mainte-nance regimen can potentially reduce toxicities and/or side-effects. The participants will thus benefit from the participation in this clinical trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2015
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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 |
Netherlands: 9
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Worldwide total number of subjects |
9
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EEA total number of subjects |
9
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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) |
9
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
Pre-assignment
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Screening details |
HIV-infected adult, in need for a switch in maintenance regimen due to adverse effects, toxicities, simplification and/or resistance. | ||||||||||
Period 1
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Period 1 title |
screening
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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PRADA II regime | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
dolutegravir
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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 |
50 mg QD
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Investigational medicinal product name |
atazanavir
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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 |
400 mg QD
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Investigational medicinal product name |
lamivudine
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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 |
300mg QD
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Period 2
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Period 2 title |
PK day
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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PK day treatment | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
dolutegravir
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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 |
50 mg QD
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Investigational medicinal product name |
atazanavir
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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 |
400 mg QD
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Investigational medicinal product name |
lamivudine
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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 |
300mg QD
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Period 3
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Period 3 title |
adult data
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Is this the baseline period? |
No | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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PRADA II regime | ||||||||||
Arm description |
- | ||||||||||
Arm type |
Active comparator | ||||||||||
Investigational medicinal product name |
dolutegravir
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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 |
50 mg QD
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Investigational medicinal product name |
atazanavir
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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 |
400 mg QD
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Investigational medicinal product name |
lamivudine
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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 |
300mg QD
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End points reporting groups
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Reporting group title |
PRADA II regime
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Reporting group description |
- | ||
Reporting group title |
PK day treatment
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Reporting group description |
- | ||
Reporting group title |
PRADA II regime
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Reporting group description |
- |
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End point title |
DTG trough levels [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
24h after dosing on PK day
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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 analyis was done, just descriptive |
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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 |
entire study
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Assessment type |
Non-systematic | ||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
PRADA II
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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? Yes | |||||||
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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 |