2024-512215-53-00Active, not recruitingPhase 3
DOR/ISL Open-label Rollover Trial
A Phase 3 Open-label Rollover Clinical Study of Doravirine/Islatravir (DOR/ISL) Once daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL Clinical Study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Jul 2026
Brief summary (registry, in English)
1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 24 May 2024
- Start date
- 27 Oct 2021
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- HIV
- EU CT number
- 2024-512215-53-00
- EudraCT number
- 2020-001191-14
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 84
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is taking or is anticipated to require any prohibited therapies.
Who the study is looking for
- Is currently receiving DOR 100 mg/ISL 0.75 mg adult fixed dose combination (FDC) tablet in an MSD-sponsored clinical study and has completed the last treatment visit.
- Is considered by the investigator to have derived clinical benefit from receiving DOR/ISL and for whom further treatment with DOR/ISL is considered clinically appropriate.
- Female is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP); or is a non-pregnant WOCBP who agrees to the following during the intervention period and for at least 6 weeks after the last dose of study intervention: Not be sexually active, or if sexually active, to use an acceptable method of contraception; or is pregnant and continues to receive study intervention (where allowed by local regulations and as appropriate based on available data/local standard-of-care guidelines).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 18 | France | Active, not recruiting |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.