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NCT05705349Active, not recruitingPhase 3

A clinical study of people with HIV-1 who have not taken antiretroviral therapy, one group will start treatment with a combination of doravirine and Islatravir compared to a different group that will start treatment with bictegravir/emtricitabine/tenofovir alafenamide

A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Doravirine/Islatravir (DOR/ISL 100 mg/0.25 mg) Once-Daily in HIV-1 Infected Treatment-Naïve Participants

Source: EU CTIS (euclinicaltrials.eu) · Last updated 10 Jul 2026

Brief summary (registry, in English)

1. To evaluate the antiretroviral activity of DOR/ISL compared to BIC/FTC/TAF, as assessed by the percentage of participants with HIV-1 RNA <50 copies/mL at Week 48. 2. To evaluate the safety and tolerability of DOR/ISL compared with BIC/FTC/TAF as assessed by review of the accumulated safety data through Week 48.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
82 (estimated)
First submitted
4 Dec 2023
Start date
29 Apr 2024
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
HIV
NCT number
NCT05705349
EU CT number
2022-502099-22-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 82
  • 22 sites in 3 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, not your situation.

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

  • Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening

Other illness

  • Has HIV-2 infection
  • Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
  • Has active hepatitis B infection (defined as hepatitis B surface antigen [HBsAg]-positive or HBV deoxyribonucleic acid [DNA]-positive).
  • Has chronic hepatitis C virus (HCV) infection (detectable HCV ribonucleic acid [RNA])

Lab values

  • Has a history or current evidence of any condition (including active tuberculosis infection), therapy, laboratory abnormality, or other circumstance (including drug or alcohol use or dependence) that might, in the opinion of the investigator, confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate

Age

  • Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or cutaneous Kaposi’s sarcoma

Who the study is looking for

  • Is an individual ≥18 years of age of any sex/gender who is HIV-1 positive with plasma HIV-1 RNA ≥500 copies/mL at screening
  • Is naïve to antiretroviral therapy (ART) defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection
  • Female is not a participant of childbearing potential (POCBP); or if a POCBP, is not pregnant or breastfeeding, and is willing to use an acceptable contraceptive method or abstain from heterosexual intercourse for study duration

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (22)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitaetsklinikum Bonn AöR
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BonnGermanyActive, not recruiting
Medical Center- University of Freiburg
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Freiburg im BreisgauGermanyActive, not recruiting
University Medical Center Hamburg-Eppendorf
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HamburgGermanyActive, not recruiting
ICH Study Center Gmbh & Co. KG
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HamburgGermanyActive, not recruiting
Klinikum Der Universitat Munchen AöR
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MunichGermanyActive, not recruiting
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital General Universitario de Elche
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ElcheSpainActive, not recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Assistance Publique Hopitaux De Paris
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BobignyFranceActive, not recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Centre Hospitalier De Tourcoing
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Tourcoing CedexFranceActive, not recruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.