Clinical Trial Results:
HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial
Summary
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EudraCT number |
2014-004331-39 |
Trial protocol |
ES |
Global end of trial date |
29 Jun 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Oct 2021
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First version publication date |
31 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 |
INDOOR
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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 |
VHIR
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Sponsor organisation address |
Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
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Public contact |
Joaquin Lopez-Soriano, VHIR, 0034 934894779, joaquin.lopez.soriano@vhir.org
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Scientific contact |
Unitat de malalties infeccioses, Fundación Vall Hebron Institut de Recerca, 0034 934893000, mcrespo@vhebron.net
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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 |
29 Jun 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 |
29 Jun 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 assess the HIV reservoir dynamics after the change of IP / r by dolutegravir in HIV-1 infected patients that they maintain suppressed the viral load (HIV RNA <50 copies / ml) with AN ART 2 and 1 IP / r
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Protection of trial subjects |
According to routine care practice and physician criteria, blood tests were performed every 3–6 months in these patients.
This study was conducted in accordance with local ethical and legal requirements. The study protocol was approved by each hospital’s local ethics committee and the Spanish Agency for Medicines and Healthcare Products (AEMPS). The study was conducted according to the Good Clinical Practice Guidelines
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Background therapy |
Antiretroviral treatment (ART) guidelines recommend the use of three active drugs to treat human immunodeficiency virus (HIV) infection in both treatment-naive and treatment-experienced patients. Nonstandard ARTs may include complex regimens that usually entail high pill burden and/or twice/day administration, and frequently recycled or partially active drugs | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Feb 2015
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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: 50
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Worldwide total number of subjects |
50
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EEA total number of subjects |
50
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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) |
50
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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 |
- | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
50 | ||||||
Number of subjects completed |
50 | ||||||
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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Switch to DTG+DRV/b | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Dolutegravir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Pillules
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Routes of administration |
Oral use
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Dosage and administration details |
2-4 daily 10mg pills, orally
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Switch to DTG+DRV/b
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Reporting group description |
- |
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End point title |
DTG+ DRV/b effectiveness [1] | ||||||||
End point description |
The primary outcome was once/day DTG+ DRV/b effectiveness, defined as the percentage of patients with a VL of 50 copies/ml or lower at last follow-up visit
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End point type |
Primary
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End point timeframe |
Last visit at end of study (17-28 months, median 25 months)
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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 statistics is given, since there are not arms nor control/placebo groups for comparison |
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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 |
End of study
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Assessment type |
Systematic | ||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||
Dictionary version |
14.1
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Reporting groups
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Reporting group title |
DTG switch
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Reporting group description |
- | ||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||
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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. | |||
Mainly it is a small retrospective study without a control group, and thus confounding factors may interfere in the results | |||
Online references |
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http://www.ncbi.nlm.nih.gov/pubmed/30723941 |