HivPhase 4DORAVIPEPNCT04233372

Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study

A Phase 4 study testing Delstrigo in people with Hiv, run by Hospital Clinic of Barcelona at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hiv
What is being tested?: Delstrigo
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 399 participants
Where: 2 sitesin 2 countries
Study dates: 27 Aug 2020to 28 Jul 2022
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

France1 site

Department and HIV & HCV Clinical Research Unit University Hospital Nantes
Nantes

Other trials in France

Spain1 site

Hospital Clínic de Barcelona
Barcelona, 08036

Other trials in Spain

About this study

Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

Conditions: Hiv
Being tested: Delstrigo
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DelstrigoDrug
Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.
1 covered tablet for day .( will be administered 28 days maximum)

Study groups in NCT04233372
Study group	Role	What they receive
Delstrigo	Experimental	Not described Receives: Drug: Delstrigo

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Participants Who Did Not Complete the 28-day PEP Regimen
Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion 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 reason.
4. Consent withdrawal
Measured: 28 days

Secondary outcomes (6)

Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Measured: 28 days
Assess the Baseline Characteristics Associated to Treatment Non-completion.
Baseline characteristics associated to treatment non-completion were identified using logistic regression model selecting variables in a stepwise fashion.The dependent variable was 'Have discontinuated the 28-days treatment'
Measured: 28 days
Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Measured: 28 days
Adherence to cART During 28-day PEP Regimen
Adherence to cART was assessed using the Simplified Medication Adherence Questionnaire (SMAQ) at day 7 and week 4. Non-adherence was defined based on questionnaire responses and pill count.
Measured: Day 0 to Day 28 (Week 4)
Proportion of Subjects That Maintain Follow-up
Absolute frequency and percentage of individuals who performed month 4 (retention rate).
Measured: Month 4
Rate of HIV Seroconversion
Number of participants who tested positive for HIV during the 12-week follow-up period after completing post-exposure prophylaxis (PEP) with Delstrigo®.
Measured: Day 0 to Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 202028 Jul 2022

First posted18 Jan 2020
Study start27 Aug 2020
Primary completion28 Jul 2022
Study completion28 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HivStudies of the same condition, open and under way.
More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 399 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04233372
Sponsor's protocol ID: DORAVIPEP
Other IDs: 2019-004140-30, 2019
Acronym: DORAVIPEP
Status last verified: Jul 2025
First submitted: 20 Dec 2019
Last updated: 10 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Inciarte A, Ugarte A, Martinez-Rebollar M, Torres B, Fernandez E, Berrocal L, Laguno M, De la Mora L, De Lazzari E, Callau P, Chivite I, Gonzalez-Cordon A, Solbes E, Rico V, Barrero L, Blanco JL, Martinez E, Ambrosioni J, Mallolas J; DORAVIPEP Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP). Open Forum Infect Dis. 2023 Jul 19;10(8):ofad374. doi: 10.1093/ofid/ofad374. eCollection 2023 Aug.
PubMed 37539061

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All Hiv trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of (Doravirine / Lamivudine / Tenofovir Disoproxil Fumarate) (Delstrigo®) as a New Strategy for Non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study
ClinicalTrials.gov ID: NCT04233372
Acronym / sponsor ID: DORAVIPEP / DORAVIPEP
Conditions: Hiv
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 399 participants (actual)
Lead sponsor: Hospital Clinic of BarcelonaUniversity, hospital or other
Study start: 27 Aug 2020 (actual)
Primary completion: 28 Jul 2022 (actual)
Study completion: 28 Jul 2022 (actual)
First posted: 18 Jan 2020 (actual)
Results: Posted 10 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects who go to emergency room for possible contact to HIV transmission receive Delstrigo as post exposition prophylaxis.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Delstrigo	Experimental	Drug: Delstrigo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DelstrigoDoravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil. 1 covered tablet for day .( will be administered 28 days maximum)	Drug	Delstrigo

Primary outcome

Proportion of Participants Who Did Not Complete the 28-day PEP Regimen
Time frame: 28 days
Proportion of subjects with treatment completion at day 28. Post exposition prophylaxis (PEP) non-completion 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 reason. 4. Consent withdrawal

6 secondary outcomes

Type of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Time frame: 28 days
Assess the Baseline Characteristics Associated to Treatment Non-completion.
Time frame: 28 days
Incidence of Clinical and Laboratory Adverse Events During 28-day PEP With DOR/3TC/TDF
Time frame: 28 days
Adherence to cART During 28-day PEP Regimen
Time frame: Day 0 to Day 28 (Week 4)
Proportion of Subjects That Maintain Follow-up
Time frame: Month 4
Rate of HIV Seroconversion
Time frame: Day 0 to Day 84

Results and safety

Results posted to the registry on 10 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delstrigo	399	285

Primary outcome: Proportion of Participants Who Did Not Complete the 28-day PEP Regimen

Time frame: 28 days. Count of participants. Unit: Participants

Measure	Delstrigo n = 399
Value	114

Population analysed: All participants who received at least one dose of PEP (Intention-To-Treat population).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from Day 0 (start of treatment) through Week 12 (approximately 84 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delstrigo	0 of 399 (0%)	123 of 399 (30.8%)	0 of 399

Limitations and caveats (from the sponsor): This was a single-arm, open-label study without a comparator group, which limits the ability to attribute outcomes solely to the intervention. Additionally, the number of participants affected per adverse event category was not specified, restricting detailed safety analysis. Follow-up rates decreased over time, potentially impacting data completeness.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37539061Inciarte A, Ugarte A, Martinez-Rebollar M, Torres B, Fernandez E, Berrocal L, Laguno M, De la Mora L, De Lazzari E, Callau P, Chivite I, Gonzalez-Cordon A, Solbes E, Rico V, Barrero L, Blanco JL, Martinez E, Ambrosioni J, Mallolas J; DORAVIPEP Study Group. Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate for Nonoccupational HIV-1 Postexposure Prophylaxis: A Prospective Open-Label Trial (DORAVIPEP). Open Forum Infect Dis. 2023 Jul 19;10(8):ofad374. doi: 10.1093/ofid/ofad374. eCollection 2023 Aug.
Individual participant dataSharing planned: Undecided

Related trials for Hiv

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Delstrigo in people with Hiv, run by Hospital Clinic of Barcelona at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Who Did Not Complete the 28-day PEP Regimen (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04233372, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.