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Active (not recruiting) Phase 3 NCT05705349

DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)

Phase 3 – large-scale trial before approval
Conditions: HIV-1 Infection

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
This is a randomized, active-controlled, double-blind clinical study designed to evaluate the antiretroviral activity, safety, and tolerability of doravirine/islatravir (DOR/ISL \[MK-8591A\]) in treatment-naïve participants with human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that DOR/ISL is non-inferior to bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) \<50 copies/mL at Week 48.
Who can participate
Inclusion Criteria: * 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 * If 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 Exclusion Criteria: * Has HIV-2 infection * Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * Has a diagnosis of an active AIDS-defining opportunistic infection within 30 days prior to screening * 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 \[RNA\]) and lab values are consistent with cirrhosis * 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 * 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
Locations 21
Argentina (1)
Fundación Huésped ( Site 5850)
CABA , Buenos Aires
Canada (1)
Hamilton Health Sciences-Urgent Care Centre ( Site 5750)
Hamilton , Ontario
Chile (1)
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 5955)
Temuco , Araucania
Colombia (1)
Ciensalud Ips S A S ( Site 6050)
Barranquilla , Atlántico
Dominican Republic (1)
Instituto Dermatológico y Cirugía de Piel "Dr. Huberto Bogaert Díaz" ( Site 8250)
Santo Domingo de Guzman , Santo Domingo Province
France (1)
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 6153)
Nice , Alpes-Maritimes
Germany (1)
Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Medizinische Klinik und Poliklinik IV, Sektio
München , Bavaria
Guatemala (1)
CLINIPHARM ( Site 8352)
Guatemala City
Israel (1)
Rambam Health Care Campus-Institute of Allergy, Clinical Immunology, ( Site 6751)
Haifa
Japan (1)
National Hospital Organization Nagoya Medical Center ( Site 6953)
Nagoya , Aichi-ken
Kenya (1)
CCR KEMRI (Center for Clinical Research) ( Site 8652)
Nairobi , Nairobi City
Malaysia (1)
Hospital Sultanah Bahiyah ( Site 7776)
Alor Star , Kedah
Mexico (1)
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran ( Site 7251)
Mexico City , Mexico City
Puerto Rico (1)
Ponce Medical School Foundation Inc. ( Site 7452)
Ponce
South Africa (1)
Josha Research ( Site 6652)
Bloemfontein , Free State
Spain (1)
Hospital General Universitario de Elche-Infectius Disease ( Site 6358)
Elche , Alicante
Switzerland (1)
University Hospital Basel-Infectiology ( Site 8151)
Basel , Canton of Basel-City
Thailand (1)
HIV Netherlands Australia Thailand Research Collaboration ( Site 7851)
Bangkok , Bangkok
Turkey (1)
Hacettepe Universite Hastaneleri ( Site 7650)
Altindağ , Ankara
United Kingdom (1)
Southmead Hospital ( Site 7952)
Bristol , Bristol, City of
United States (1)
Pueblo Family Physicians ( Site 5674)
Phoenix , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.03.2023
Completion date
05.08.2029
Registry ID
NCT05705349
Source
anzctr
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