Clinical Trial Results:
Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals.
Summary
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EudraCT number |
2018-003921-27 |
Trial protocol |
ES |
Global end of trial date |
24 Aug 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
21 Dec 2023
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First version publication date |
21 Dec 2023
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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 |
DORAGEN
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04097925 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
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Sponsor organisation address |
Ctra. de Canyet s/n, Badalona, Spain, 08916
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Public contact |
Antonio Navarro, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la, +34 675335888, anavarro@irsicaixa.es
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Scientific contact |
Antonio Navarro, Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la, +34 675335888, anavarro@irsicaixa.es
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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 |
24 Aug 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 |
24 Aug 2020
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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 |
Determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.
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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 |
18 Feb 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
30
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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 30 HIV-infected patients were selected at the screening phase. Recruitment was started 18-feb-2020 and the last patient recruited was 28-may-2020. | ||||||||||
Pre-assignment
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Screening details |
30 patient were screened. | ||||||||||
Pre-assignment period milestones
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Number of subjects started |
30 | ||||||||||
Number of subjects completed |
30 | ||||||||||
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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DOR/TAF+FTC | ||||||||||
Arm description |
Doravirine administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC) and administered orally once daily | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Doravirine/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 |
Doravirine 100 mg table + Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
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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 |
Doravirine (MK-1439) 100 mg administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC 25/200 mg) and administered orally once daily during 16 weeks Doravirine: Doravirine 100 mg tablet Descovy: Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 |
DOR/TAF+FTC
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Reporting group description |
Doravirine administered orally once daily in combination with Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet (Descovy® TAF/FTC) and administered orally once daily | ||
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 |
Concentration of Doravirine in Seminal Plasma Fluid [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
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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 Doravirine concentration in different anatomical reservoirs |
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Notes [2] - Only male participants were assessed on this endpoint [3] - 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 Doravirine in Cervicovaginal Fluid [4] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks after switching to Doravirine plus TAF/FTC
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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 Doravirine concentration in different anatomical reservoirs |
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Notes [5] - Only female participants were assessed on this endpoint [6] - 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 |
Number of Participants With HIV-1 RNA Seminal Plasma <40 Copies/mL [7] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
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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 number of participants with HIV-2 RNA <40 copies/mL in different anatomical reservoirs |
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Notes [8] - Only male participants were assessed on this endpoint [9] - 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 |
Number of Participants With HIV-1 RNA Cervicovaginal Fluid <40 Copies/mL [10] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
8 weeks after switching (from baseline visit) to Doravirine plus TAF/FTC
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Notes [10] - 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 number of participants with HIV-2 RNA <40 copies/mL in different anatomical reservoirs |
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Notes [11] - Only female participants were assessed on this endpoint [12] - Only female participants were assessed on this endpoint |
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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 |
16 weeks
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
17.1
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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 16 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 |