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New HIV prevention pill shows promise in Real-World study

NCT ID NCT04233372

Prevention Sponsor: Hospital Clinic of Barcelona Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether a three-drug HIV pill called Delstrigo can prevent HIV infection when taken for 28 days after a possible exposure. About 400 adults who came to the emergency room after a potential HIV contact took the pill daily. Researchers tracked how many completed the full course and what side effects occurred.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Delstrigo (doravirine, lamivudine, tenofovir disoproxil fumarate)
What this could lead to
If successful, this could provide a simpler, well-tolerated option for preventing HIV after a potential exposure.
What could go wrong
This is a single-site, open-label study without a comparison group, so results may not apply broadly. Some people may not complete the full 28-day course.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

399 people

The number who actually took part.

Started

Aug 2020

Finished

Jul 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS HIV infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV

Contacts and locations

Locations

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

    Nantes, France

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

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