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Fut, nem toboroz3. fázis

DOR/ISL Open-label Rollover Trial

Key facts

Where
Bordeaux, Montpellier Cedex 5, Nice, Paris és Paris Cedex 18, FranciaországSee the 5 sites
Phase
3. fázis

Where in Franciaország

  • Centre hospitalier Universitaire de BordeauxBordeaux, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországNo longer taking part
  • Centre Hospitalier Universitaire de NiceNice, FranciaországNo longer taking part
  • Assistance Publique Hopitaux de ParisParis, FranciaországNo longer taking part
  • Assistance Publique Hopitaux De ParisParis Cedex 18, FranciaországNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Merck Sharp & Dohme LLC
Trial code
EU 2024-512215-53-00
Record updated
2026. július 29.
Original description
1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data.Read full original descriptionShow less

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

1. To evaluate the safety and tolerability of Doravirine/Islatravir (DOR/ISL) as assessed by accumulated safety data.

Inclusion: 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).

Exclusion: Is taking or is anticipated to require any prohibited therapies.

EU CTIS 2024-512215-53-00