Clinical Trial Results:
Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).
Summary
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EudraCT number |
2018-002310-12 |
Trial protocol |
ES |
Global end of trial date |
03 Dec 2019
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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-380-4663
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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 |
Ctra Canyet s/n, Badalona/Barcelona, Spain, 08916
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Public contact |
Unidad de VIH, Hospital Universitari de Bellvitge, 0034 9333590112876, dpodzamczer@bellvitgehospital.cat
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Scientific contact |
Unidad de VIH, Hospital Universitari de Bellvitge, 0034 9333590112876, anavarroa@bellvitgehospital.cat
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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 |
03 Mar 2020
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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 |
03 Dec 2019
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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 evaluate HIV viral kinetics in seminal plasma and rectal fluid, and cervicovaginal fluid in HIV-1 infected ART naïve male and female individuals, respectively, initiating Bictegravir/FTC/TAF.
- To determine Bictegravir concentrations in fluid and tissue from the male and female genital tract (seminal plasma and cervicovaginal fluid) and rectal compartment (rectal tissue and rectal fluid) in HIV-1 infected male and female individuals receiving ART with Bictegravir/FTC/TAF.
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Protection of trial subjects |
Although assessed treatment is approved and is used in routine care, 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 |
01 Oct 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: 24
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Worldwide total number of subjects |
24
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EEA total number of subjects |
24
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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) |
24
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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 25 HIV-infected patients were selected at the screening phase, and 1 patient was screening failure. Recruitment was started 01-feb-2019 and the last patient recruited was 28-may-2019. First | ||||||||||
Pre-assignment
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Screening details |
25 patient were screened. 1 patient was screening failure. | ||||||||||
Pre-assignment period milestones
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Number of subjects started |
25 [1] | ||||||||||
Number of subjects completed |
24 | ||||||||||
Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Screening failure: 1 | ||||||||||
Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: 25 patients were screened. 1 patient was screening failure |
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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/Tenofovir Alafenamide Fumarate/Emtricitabine treatment | ||||||||||
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 Bictegravir /200 mg Emtracitibine/Tenofovir alafenamide fumarate 25 mg
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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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Subject analysis sets
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Subject analysis set title |
Overall analysis
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||
Subject analysis set description |
All patients were included in this analysis. Full analysis assessed the differences in viral suppression efficacy on the different reservoirs evaluated
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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/Tenofovir Alafenamide Fumarate/Emtricitabine treatment | ||
Subject analysis set title |
Overall analysis
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All patients were included in this analysis. Full analysis assessed the differences in viral suppression efficacy on the different reservoirs evaluated
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End point title |
HIV-1 RNA decay in seminal plasma from baseline and up to 24 weeks [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 24
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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 Bictegravir concentration in different anatomical reservoirs |
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Notes [2] - Only male participants were assessed on this endpoint |
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No statistical analyses for this end point |
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End point title |
Concentration of Bictegravir in seminal plasma, at week4 after initiation a first ART regimen with Bictegravir/FTC/TAF. [3] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 4
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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 Bictegravir concentration in different anatomical reservoirs |
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Notes [4] - Only male participants were assessed on this endpoint |
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No statistical analyses for this end point |
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End point title |
HIV-1 RNA decay in rectal fluid from baseline and up to 24 weeks [5] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
week 24
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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 RNA decay in different anatomical reservoirs |
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Notes [6] - Only male participants were assessed on this endpoint |
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No statistical analyses for this end point |
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End point title |
Concentration of Bictegravir in rectal fluid at weeks 4 after initiation a first ART regimen with Bictegravir/FTC/TAF. [7] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
weeks 4.
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Notes [7] - 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 Bictegravir concentration in different anatomical reservoirs |
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Notes [8] - Only male participants were assessed on this endpoint |
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No statistical analyses for this end point |
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End point title |
Concentration of Bictegravir in cervicovaginal fluid at weeks 12 after initiation a first ART regimen with Bictegravir/FTC/TAF. [9] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Bictegravir concentration was assessed at week 12
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Notes [9] - 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 Bictegravir concentration in different anatomical reservoirs |
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Notes [10] - Only female participants were assessed on this endpoint |
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No statistical analyses for this end point |
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End point title |
HIV-1 RNA decay in blood plasma from baseline and up to 24 weeks | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
HIV RNA decay in blood plasma was assessed at: Day 3, Day 7, Day 14, week 4, week 12 and week 24
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No statistical analyses for this end point |
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End point title |
Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in male participants | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
week 12
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Notes [11] - Male participants data |
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No statistical analyses for this end point |
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End point title |
Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in female participants | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
week 12
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Notes [12] - Female participants |
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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 |
Adverse event were reported since baseline visit to w24 and follow-up visit
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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 event were reported during the 24 weeks of follow up |
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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/32945851 |