Clinical Trial Results:
Tenofovir DP concentrations in seminal cells and semen quality in HIV-1 infected patients receiving a TAF containing regimen
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Summary
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EudraCT number |
2016-001371-69 |
Trial protocol |
ES |
Global end of trial date |
19 Oct 2017
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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 |
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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 |
EVITAs
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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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 |
16 Aug 2017
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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 |
19 Oct 2017
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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 intracellular concentrations of tenofovir diphosphate (TFV-DP) in seminal mononuclear (SMC) cells of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI.
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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 Jul 2016
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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 15 HIV-infected patients were selected at the screening phase. | ||||||||||
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Pre-assignment
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Screening details |
15 patients were screened | ||||||||||
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Pre-assignment period milestones
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Number of subjects started |
15 | ||||||||||
Number of subjects completed |
15 | ||||||||||
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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 | ||||||||||
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Arms
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Arm title
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EVG/c/FTC/TAF | ||||||||||
Arm description |
Elvitgeravir boosted with cobicistat and Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet and administered orally once daily | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Elvitegravir, cobicistat, Emtricitabine and 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 |
elvitegravir 150 mg, cobicistat 150 mg, Emtricitabine 200 mg, tenofovir alafenamide fumarate 10 mg once daily.
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End points reporting groups
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Reporting group title |
EVG/c/FTC/TAF
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Reporting group description |
Elvitgeravir boosted with cobicistat and Tenofovir alafenamide (TAF) and emtricitabine (FTC) co-formulated as single tablet and administered orally once daily | ||
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End point title |
Tenofovir alafenamide fumarate concentration in seminal plasma [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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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 |
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| No statistical analyses for this end point | |||||||||
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End point title |
Tenofovir alafenamide fumarate concentration in blood plasma [2] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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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 |
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| No statistical analyses for this end point | |||||||||
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End point title |
tenofovir diphosphate (tenofovir alafenamide fumarate) concentration in peripheral blood mononuclear cells [3] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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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 |
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| No statistical analyses for this end point | |||||||||
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End point title |
tenofovir diphosphate (tenofovir alafenamide fumarate) concentration in seminal mononuclear cells [4] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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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 |
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| No statistical analyses for this end point | |||||||||
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End point title |
Tenofovir alafenamide fumarate seminal plasma/blood plasma concentration ratio [5] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 week
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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 |
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| No statistical analyses for this end point | |||||||||
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End point title |
tenofovir diphosphate seminal mononuclear cells/ peripheral blood mononuclear cells concentration ratio [6] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
12 weeks
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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 |
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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 |
14 weeks
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Assessment type |
Systematic | ||
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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 | |||
