Phase 4
N=399
Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
Hiv
Bottom Line
View on ClinicalTrials.gov: NCT04233372 ↗Enrolled (actual)
399
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Proportion of Participants Who Did Not Complete the 28-day PEP Regimen — 114 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Delstrigo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Clinic of Barcelona
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Did Not Complete the 28-day PEP Regimen |
114 | — |
| SECONDARY Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF |
150; 28; 5 | — |
| SECONDARY Assess the Baseline Characteristics Associated to Treatment Non-completion. |
1.20; 0.94; 0.42; 0.57; 0.98; 1.45 | — |
| SECONDARY Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF |
123 | — |
| SECONDARY Adherence to cART During 28-day PEP Regimen |
336; 281 | — |
| SECONDARY Proportion of Subjects That Maintain Follow-up |
243 | — |
| SECONDARY Rate of HIV Seroconversion |
— | — |
Summary
Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.
Eligibility Criteria
Inclusion Criteria
- Subjects attending emergency room due to potential HIV exposition of either sex:
- Aged 18 years or more.
- Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin prophylaxis post-exposition with three antiretroviral drugs.
- Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
- Individuals able to do follow up correctly.
Exclusion Criteria
- Pregnant women or nursing mothers or women trying to conceive during the study period.
- Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens.
- Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
- Allergic reactions or intolerance to the compounds of the study treatment regiments
Data sourced from ClinicalTrials.gov (NCT04233372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.