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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05705349
Registration number
NCT05705349
Ethics application status
Date submitted
20/01/2023
Date registered
30/01/2023
Titles & IDs
Public title
DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053)
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Scientific title
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
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Secondary ID [1]
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2022-502099-22-00
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Secondary ID [2]
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8591A-053
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DOR/ISL
Treatment: Drugs - BIC/FTC/TAF
Treatment: Drugs - Placebo to DOR/ISL
Treatment: Drugs - Placebo to BIC/FTC/TAF
Experimental: DOR/ISL - Participants take DOR/ISL and placebo to BIC/FTC/TAF once daily (qd) for 96 weeks.
Active comparator: BIC/FTC/TAF - Participants take BIC/FTC/TAF and placebo to DOR/ISL qd for 96 weeks.
Treatment: Drugs: DOR/ISL
Fixed dose combination tablet containing DOR/ISL 100 mg/0.25 mg taken by mouth.
Treatment: Drugs: BIC/FTC/TAF
Fixed dose combination tablet containing BIC/FTC/TAF 50 mg/200 mg/25 mg taken by mouth.
Treatment: Drugs: Placebo to DOR/ISL
Placebo tablet matched to DOR/ISL tablet taken by mouth.
Treatment: Drugs: Placebo to BIC/FTC/TAF
Placebo tablet matched to BIC/FTC/TAF tablet taken by mouth.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of participants with human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL at Week 48
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Assessment method [1]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay with a lower limit of detection of \<50 copies/mL.
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Timepoint [1]
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Week 48
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Primary outcome [2]
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Percentage of participants experiencing =1 adverse event (AE) through Week 48
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Assessment method [2]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [2]
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Up to 48 weeks
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Primary outcome [3]
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Percentage of participants discontinuing from study treatment due to an AE through Week 48
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Assessment method [3]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [3]
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Up to 48 weeks
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Secondary outcome [1]
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Percentage of participants with HIV-1 RNA <50 copies/mL at Week 96
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Assessment method [1]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
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Timepoint [1]
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Week 96
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Secondary outcome [2]
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Percentage of participants with HIV-1 RNA <200 copies/mL at Week 48
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Assessment method [2]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Percentage of participants with HIV-1 RNA <200 copies/mL at Week 96
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Assessment method [3]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay with a lower limit of detection of \<50 copies/mL.
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Timepoint [3]
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Week 96
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Secondary outcome [4]
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Change from baseline in cluster of differentiation 4+ (CD4+) T-cells at Week 48
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Assessment method [4]
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CD4+ T-cells are quantified with a T and B lymphocyte and natural killer cell (TBNK) panel.
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Timepoint [4]
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Baseline (Day 1) and Week 48
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Secondary outcome [5]
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Change from baseline in CD4+ T-cells at Week 96
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Assessment method [5]
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CD4+ T-cells are quantified with a TBNK panel.
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Timepoint [5]
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Baseline (Day 1) and Week 96
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Secondary outcome [6]
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Incidence of viral drug resistance
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Assessment method [6]
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Plasma samples will be collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and viral susceptibility as applicable during the study.
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Timepoint [6]
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Up to 96 weeks
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Secondary outcome [7]
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Change from baseline in body weight at Week 48
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Assessment method [7]
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Body weight will be collected throughout the study.
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Timepoint [7]
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Baseline (Day 1) and Week 48
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Secondary outcome [8]
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Change from baseline in body weight at Week 96
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Assessment method [8]
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Body weight will be collected throughout the study.
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Timepoint [8]
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Baseline (Day 1) and Week 96
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Secondary outcome [9]
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Percentage of participants experiencing =1 AE through Week 96
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Assessment method [9]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [9]
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Up to 96 weeks
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Secondary outcome [10]
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Percentage of participants discontinuing from study treatment due to an AE through Week 96
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Assessment method [10]
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Timepoint [10]
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Up to 96 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2026
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05705349
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for public queries
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1-888-577-8839
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05705349