Clinical Trial Results:
Virological and immunological safety of a dose reduction strategy antiretroviral regimen with efavirenz / tenofovir / emtricitabine
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Summary
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EudraCT number |
2012-004970-24 |
Trial protocol |
ES |
Global end of trial date |
21 Jul 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Aug 2025
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First version publication date |
09 Aug 2025
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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 |
A-TRI-WEEK
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01778413 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundació Clínic per a la Recerca Biomèdica
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Sponsor organisation address |
C. Roselló, 143, Barcelona, Spain,
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Public contact |
Anna Cruceta, CTU- Clinical Trial unit. Farmacologia clinica, ACRUCETA@recerca.clinic.cat
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Scientific contact |
Anna Cruceta, CTU- Clinical Trial unit. Farmacologia clinica, ACRUCETA@recerca.clinic.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 |
21 Jul 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Nov 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
21 Jul 2015
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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 |
The main objective of this study was to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per weeks in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.
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Protection of trial subjects |
The study followed the Declaration of Helsinki and Spanish regulations (RD 223/2004).
Approval was obtained from the Ethics Committee and AEMPS before initiation.
Participants gave written informed consent after receiving oral and written information.
Confidentiality was ensured through coded data and restricted access.
Civil liability insurance was contracted by the sponsor.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2013
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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: 61
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Worldwide total number of subjects |
61
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EEA total number of subjects |
61
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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) |
61
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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 |
The study planned to recruit 60 adult HIV-1-infected patients with sustained virologic suppression on ATRIPLA® for over 2 years. Recruitment was conducted at a single center (Hospital Clínic de Barcelona) over a 12-month period. All participants provided written informed consent prior to any study procedures. | |||||||||
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Pre-assignment
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Screening details |
Screening included verification of inclusion/exclusion criteria, medical history, physical exam, vital signs, and laboratory tests. Eligible patients were randomized after baseline assessments. | |||||||||
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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 |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Atripla OD | |||||||||
Arm description |
Atripla (600 mg/200 mg/245 mg) one time a day. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
ATRIPLA
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Investigational medicinal product code |
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Other name |
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Once daily
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Arm title
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Atripla 3W | |||||||||
Arm description |
Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
ATRIPLA
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Investigational medicinal product code |
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Other name |
Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Participants will receive one tablet of ATRIPLA® (600 mg efavirenz / 200 mg emtricitabine / 245 mg tenofovir disoproxil fumarate) orally, three times per week (on Monday, Wednesday, and Friday) for a total of 24 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Atripla OD
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Reporting group description |
Atripla (600 mg/200 mg/245 mg) one time a day. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Atripla 3W
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Reporting group description |
Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Atripla OD
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Reporting group description |
Atripla (600 mg/200 mg/245 mg) one time a day. | ||
Reporting group title |
Atripla 3W
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Reporting group description |
Atripla (600 mg/200 mg/245 mg) three days a week (Mondays, Wednesdays and Fridays). | ||
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End point title |
Proportion of Patients Free of Treatment Failure (Noncompleter = Failure) at 24 Weeks [1] | |||||||||||||||
End point description |
Treatment failure defined as any of the following possibilities occurring within the 24-week study framework: virological
failure (confirmed plasma viral load 37 copies/ml), discontinuation of the antiretroviral therapy schedule irrespective of
the reason, consent withdrawal, lost to follow-up, pregnancy, inability to comply with the study or any other reason that
could make the doctor in charge consider the cessation of the study.
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End point type |
Primary
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End point timeframe |
24 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: No formal statistical hypothesis test was performed for the primary endpoint because all patients in both arms (OD and 3W) remained free of treatment failure at 24 weeks. As there were zero events in both groups, a p-value was not applicable. A 95% confidence interval for the difference in proportions was estimated using Newcombe’s method. |
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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 |
24 weeks
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Adverse event reporting additional description |
Adverse Event Reporting Description AE/SAE definitions were consistent with ClinicalTrials.gov, but also included clinically significant lab abnormalities and events related to overdose, abuse, or withdrawal.
AEs were collected systematically at baseline, weeks 12 and 24 in both arms, and at weeks 1, 2, 4, 6, and 8 in the 3-day/week arm. Gradi
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Assessment type |
Systematic | |||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
DAIDS Table | |||||||||||||||||||||
Dictionary version |
1.0
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Reporting groups
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Reporting group title |
ATRIPLA 3W
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Reporting group description |
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Reporting group title |
ATRIPLA 0D
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||||||||
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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. | |||
| Small sample size and short follow-up. All participants were stable on Atripla, limiting generalizability to other regimens or populations. No economic evaluation included. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/29746294 |
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