Clinical Trial Results:
Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals
Summary
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EudraCT number |
2018-000302-39 |
Trial protocol |
ES |
Global end of trial date |
25 Sep 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
17 Oct 2021
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First version publication date |
17 Oct 2021
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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 |
IN-ES-380-4475
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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 |
Fight AIDS and Infectious diseases foundation
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Sponsor organisation address |
Cta de Canyet s/n, Badalona, Spain,
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Public contact |
Albert Tuldrà, Fight AIDS and Infectious diseases foundation, 0034 934657897, atuldra@flsida.org
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Scientific contact |
Albert Tuldrà, Fight AIDS and Infectious diseases foundation, 0034 934657897, atuldra@flsida.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 |
05 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
25 Sep 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
25 Sep 2018
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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 Bictegravir concentrations in CSF and to estimate penetration into the CNS.
-To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.
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Protection of trial subjects |
The sponsor contracted an insurance as a mandatory aspect defined in the legal framework of the country site due a different procedures performed during the clinical trial out of routine clinical practice.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
09 Apr 2018
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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: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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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) |
15
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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 |
Subjects who met inclusion criteria and accepted to sign the informed consent to participate will be cited for a screening visit. A total of 16 HIV-infected patients were selected at the screening phase. Recruitment started on 23/Jul/2018, last patient recurited was on 31/Jul/2018. | ||||||
Pre-assignment
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Screening details |
16 patients were screened. One patient didn't meet all inclusion criteria | ||||||
Pre-assignment period milestones
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Number of subjects started |
15 | ||||||
Number of subjects completed |
15 | ||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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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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BIC/TAF/FTC | ||||||
Arm description |
Bictegravir/Emtricitabine/Tenofovir alafenamide fumarate | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Bictegravir/Emtricitabine/Tenofovir alafenamide fumarate
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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 of Bictegravir/ 200 mg of Emtricitabine/25 mg of Tenofovir alafenamide fumarate
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial (overall period)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
BIC/TAF/FTC
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Reporting group description |
Bictegravir/Emtricitabine/Tenofovir alafenamide fumarate |
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End point title |
Total Bictegravir concentrations in cerebrospinal fluid. [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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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: Data reported has been a descriptive analysis, which shows the total Bictegravir concentration in CSF |
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No statistical analyses for this end point |
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End point title |
Unbound Bictegravir concentrations in cerebrospinal fluid. [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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Notes [2] - 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: Data reported has been a descriptive analysis, which shows the unbound Bictegravir concentration in CSF |
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No statistical analyses for this end point |
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End point title |
Total Bictegravir concentrations in blood plasma [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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Notes [3] - 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: Data reported has been a descriptive analysis, which shows the total Bictegravir concentration in blood plasma |
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No statistical analyses for this end point |
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End point title |
Bictegravir CSF/plasma ratio [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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Notes [4] - 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: Data reported has been a descriptive analysis, which shows the Bictegravi-CSF/blood plasma ratio |
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No statistical analyses for this end point |
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End point title |
CSF HIV-1 RNA copies [5] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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Notes [5] - 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: Data reported has been a descriptive analysis, which shows the HIV-1 viral load in CSF |
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No statistical analyses for this end point |
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End point title |
HIV-1 RNA in blood plasma. [6] | ||||||
End point description |
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End point type |
Primary
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End point timeframe |
w12
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Notes [6] - 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: Data reported has been a descriptive analysis, which shows the HIV-1 viral load in blood plasma |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
w12
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
22.1
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non-serious adverse events were reported |
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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 | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/31784745 |