Clinical Trial Results:
Evaluation of (doravirine / lamivudine / tenofovir disoproxil fumarate) (Delstrigo®) as a New Strategy for non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study (DORAVIPEP).
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Summary
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EudraCT number |
2019-004140-30 |
Trial protocol |
ES |
Global end of trial date |
28 Jul 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
27 Aug 2025
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First version publication date |
27 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 |
DORAVIPEP
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04233372 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Fundació Clinic per a la Recerca Biomèdica
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Sponsor organisation address |
C/ ROSSELLO, 149 - 153, Barcelona, Spain,
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Public contact |
Joan Albert Arnaiz, CTU CLINIC, 34 932279838, jaarnaiz@clinic.cat
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Scientific contact |
Joan Albert Arnaiz, CTU CLINIC, 34 932279838, jaarnaiz@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 |
28 Jul 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Jul 2022
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Jul 2022
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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 estimate the proportion of subjects who correctly complete (for 28 days) the entire antiretroviral treatment proposed in the study.
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Protection of trial subjects |
Participants provided written informed consent in accordance with the Declaration of Helsinki. Personal data were anonymized and handled under strict confidentiality protocols. Clinical follow-up was conducted at multiple time points to monitor safety, including laboratory tests and adverse event assessments. Adherence to treatment was evaluated using the validated SMAQ questionnaire
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Sep 2020
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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: 399
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Worldwide total number of subjects |
399
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EEA total number of subjects |
399
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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) |
399
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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 |
1535 subjects received PEP prescriptions between September 2020 and February 2022 | ||||||||||||||
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Pre-assignment
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Screening details |
406 subjects Screened subjects: met PEP criteria and were visited in the emergency department of Hospital Clínic of Barcelona. 1 subject was a screening failure. 405 subjects Entered the study: 6 subjects were excluded after the initial evalution because they didn't meet the selection criteria (n=1) and/or had multiple entries (n=5). | ||||||||||||||
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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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DOR/3TC/TDF | ||||||||||||||
Arm description |
Single-arm with single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate for 28 days. | ||||||||||||||
Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Doravirine / lamivudine / tenofovir disoproxil fumarate
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Investigational medicinal product code |
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Other name |
Delstrigo®
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Pharmaceutical forms |
Coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.
1 coated tablet for day.
Treatment will be administered 28 days maximum
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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 |
DOR/3TC/TDF
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Reporting group description |
Single-arm with single-tablet regimen of doravirine/lamivudine/tenofovir disoproxil fumarate for 28 days. | ||
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End point title |
Proportion of Participants Who Did Not Complete the 28-day PEP Regimen [1] | ||||||||
End point description |
PEP noncompletion is considered in cases:
1. If the subject dies.
2. Does not go to visits (loss of follow-up)
3. Change or suspend the treatment under study for any
4. Consent withdrawal
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End point type |
Primary
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End point timeframe |
28 days
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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: The primary endpoint (proportion of participants who did not complete the 28-day PEP regimen) was analyzed using descriptive statistics. Absolute frequencies and percentages were reported, along with 95% confidence intervals. The analysis was performed on the intention-to-treat (ITT) population. This approach is appropriate given the nature of the endpoint and the single-arm design of the study. |
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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 |
9Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days).
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Adverse event reporting additional description |
AEs were assessed via clinical interview, lab tests, and documented in the CRF using MedDRA. Severity (WHO grading), causality, and outcome were recorded. SAEs and treatment-related AEs were tracked. Monitoring included spontaneous reporting and structured follow-up.
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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 |
23.1
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Reporting groups
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Reporting group title |
DOR/3TC/TDF
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Reporting group description |
ITT population. All participants who received at least one dose of DOR/3TC/TDF (Delstrigo®) for nonoccupational HIV-1 postexposure prophylaxis. | ||||||||||||||||||||||||||||||
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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. | |||
| Open-label, single-arm design limits causal inference. PrEP rollout may have reduced seroconversion rates. COVID-19 impacted follow-up and AE reporting. MSM-focused sample limits generalizability. Adherence self-reported. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/37539061 |
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