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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04223791
Registration number
NCT04223791
Ethics application status
Date submitted
8/01/2020
Date registered
10/01/2020
Date last updated
4/03/2024
Titles & IDs
Public title
Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018)
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Scientific title
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF)
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Secondary ID [1]
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MK-8591A-018
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Secondary ID [2]
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0
8591A-018
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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 Infection
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Condition category
Condition code
Infection
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0
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0
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Acquired immune deficiency syndrome (AIDS / HIV)
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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 BIC/FTC/TAF
Treatment: Drugs - Placebo to FDC DOR/ISL
Experimental: DOR/ISL - A fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) for 144 weeks; and placebo to Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) for 96 weeks.
Active Comparator: BIC/FTC/TAF - 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), 25 mg tenofovir alafenamide (TAF) for 144 weeks, and placebo to FDC DOR/ISL for 96 weeks. Participants will be offered the option to receive open-label FDC DOR/ISL from Week 144 to Week 156.
Treatment: Drugs: DOR/ISL
100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
Treatment: Drugs: BIC/FTC/TAF
50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
Treatment: Drugs: Placebo to BIC/FTC/TAF
Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
Treatment: Drugs: Placebo to FDC DOR/ISL
Placebo to FDC DOR/ISL in a tablet taken orally, once daily
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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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Participants With Human Immunodeficiency Virus 1 Ribonucleic Acid (HIV-1 RNA) =50 Copies/mL at Week 48
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Assessment method [1]
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA =50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
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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 With One or More Adverse Events (AEs) up to 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experienced an AE up to week 48 is presented.
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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 Who Discontinued Study Intervention Due to an AE up to Week 48
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Assessment method [3]
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0
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinued study intervention due to an AE up to week 48 is presented.
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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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0
Participants With HIV-1 RNA =50 Copies/mL at Week 96
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Assessment method [1]
0
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA =50 copies/mL at Week 96 is presented.
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Timepoint [1]
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0
Week 96
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Secondary outcome [2]
0
0
Participants With HIV-1 RNA =50 Copies/mL at Week 144
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Assessment method [2]
0
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA =50 copies/mL at Week 144 is presented.
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Timepoint [2]
0
0
Week 144
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Secondary outcome [3]
0
0
Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48
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Assessment method [3]
0
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA snapshot missing data approach
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Timepoint [3]
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0
Week 48
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Secondary outcome [4]
0
0
Percentage of Participants With HIV-1 RNA <40 Copies/mL at Week 48
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Assessment method [4]
0
0
The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 copies/mL at Week 48 is presented using the FDA snapshot missing data approach.
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Timepoint [4]
0
0
Week 48
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Secondary outcome [5]
0
0
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 96
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Assessment method [5]
0
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 96 is presented.
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Timepoint [5]
0
0
Week 96
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Secondary outcome [6]
0
0
Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 144
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Assessment method [6]
0
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The Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL was used to measure the HIV-1 RNA level in blood samples obtained at each visit. The percentage of participants with HIV-1 RNA <40 or <50 copies/mL at Week 144 is presented.
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Timepoint [6]
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Week 144
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Secondary outcome [7]
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Change From Baseline in Cluster of Differentiation-positive (CD4+) T-cell Count at Week 48
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Assessment method [7]
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Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 48 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
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Timepoint [7]
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Baseline and Week 48
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Secondary outcome [8]
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Change From Baseline in CD4+ T-cell Count at Week 96
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Assessment method [8]
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Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 96 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
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Timepoint [8]
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Baseline and Week 96
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Secondary outcome [9]
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Change From Baseline in CD4+ T-cell Count at Week 144
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Assessment method [9]
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Blood samples were used to measure CD4+ T-cell count. Baseline measurement of CD4+ T-cell count is defined as the day 1 value for each participant. Change from baseline in CD4+ T-cell count at week 144 using the data as observed (DAO) approach is presented. A negative value indicates a mean decrease in CD4+ T-cell count from baseline and a positive value indicates a mean increase in CD4+ T-cell count from baseline.
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Timepoint [9]
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Baseline and Week 144
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Secondary outcome [10]
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Participants With Viral Drug Resistance-associated Substitutions at Week 48
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Assessment method [10]
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Viral drug resistance is defined as participants with confirmed HIV-1 RNA =400 copies/mL having genotypic or phenotypic evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
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Timepoint [10]
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Week 48
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Secondary outcome [11]
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Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
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Assessment method [11]
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Viral drug resistance is defined as participants with confirmed HIV-1 RNA =400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
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Timepoint [11]
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Week 96
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Secondary outcome [12]
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Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 144
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Assessment method [12]
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Viral drug resistance is defined as participants with confirmed HIV-1 RNA =400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance is presented.
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Timepoint [12]
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Week 144
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Secondary outcome [13]
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Change From Baseline in Body Weight at Week 48
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Assessment method [13]
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Body weight was measured and recorded at baseline and week 48. Participants removed their shoes and wore a single layer of clothing at each measurement. The mean change from baseline in body weight at week 48 is presented.
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Timepoint [13]
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Baseline and Week 48
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Secondary outcome [14]
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Change From Baseline in Body Weight at Week 96
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Assessment method [14]
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Body weight was measured and recorded at baseline and week 96. Participants removed their shoes and wore a single layer of clothing at each measurement.
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Timepoint [14]
0
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Baseline and Week 96
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Secondary outcome [15]
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Change From Baseline in Body Weight at Week 144
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Assessment method [15]
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Body weight was measured and recorded at baseline and week 144. Participants removed their shoes and wore a single layer of clothing at each measurement.
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Timepoint [15]
0
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Baseline and Week 144
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Secondary outcome [16]
0
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Percentage of Participants With One or More AEs up to Week 144
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Assessment method [16]
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0
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [16]
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0
Up to Week 144
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Secondary outcome [17]
0
0
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 144
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Assessment method [17]
0
0
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
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Timepoint [17]
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0
Up to Week 144
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Eligibility
Key inclusion criteria
- Is HIV-1 positive with plasma Human Immunodeficiency Virus 1 (HIV-1) RNA <50 copies/mL
at screening.
- Has been receiving BIC/FTC/TAF therapy with documented viral suppression (HIV-1 RNA
<50 copies/mL) for =3 months prior to signing informed consent and has no history of
prior virologic treatment failure on any past or current regimen.
- Female is eligible to participate if she is not pregnant or breastfeeding, and at
least one of the following conditions applies: Is not a woman of childbearing
potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be
abstinent from heterosexual intercourse as their preferred and usual lifestyle; a
WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as
required by local regulations) within 24 hours before the first dose of study
intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous
result), a serum pregnancy test is required. In such cases, the participant must be
excluded from participation if the serum pregnancy result is positive.
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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?
No
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Key exclusion criteria
- Has HIV-2 infection.
- Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B
Virus (HBV) co-infection.
- Has a history of malignancy =5 years prior to signing informed consent except for
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
or cutaneous Kaposi's sarcoma.
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune
modulators, or any prohibited therapies.
- Is currently participating in or has participated in a clinical study with an
investigational compound or device from 45 days prior to Day 1 through the study
treatment period.
- Has a documented or known virologic resistance to DOR.
- Female expects to conceive or donate eggs at any time during the study.
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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
Active, not 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
18/02/2020
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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
25/02/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
643
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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St Vincent's Hospital ( Site 3807) - Darlinghurst
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Recruitment hospital [2]
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Taylor Square Private Clinic ( Site 3804) - Darlinghurst
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Recruitment hospital [3]
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Holdsworth House Medical Practice ( Site 3800) - Sydney
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Recruitment hospital [4]
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Holdsworth House Medical Practice - Brisbane ( Site 3810) - Brisbane
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Recruitment hospital [5]
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Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 3812) - Herston
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Recruitment hospital [6]
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The Alfred Hospital ( Site 3802) - Melbourne
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Recruitment hospital [7]
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Prahran Market Clinic (PMC) ( Site 3806) - Melbourne
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2010 - Sydney
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Recruitment postcode(s) [3]
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4006 - Brisbane
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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3181 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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Minnesota
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Missouri
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New Jersey
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New York
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Texas
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United States of America
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Washington
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Austria
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Steiermark
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Austria
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Wien
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Finland
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Uusimaa
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Ain
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France
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Alpes-Maritimes
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France
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Bouches-du-Rhone
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France
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Hauts-de-Seine
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France
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Herault
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France
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Loire-Atlantique
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France
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Loiret
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Paris
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Nordrhein-Westfalen
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Germany
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Berlin
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Germany
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Hamburg
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Lombardia
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Milano
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Italy
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Napoli
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Japan
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Aichi
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Japan
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Osaka
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Japan
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Tokyo
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Puerto Rico
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Ponce
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Puerto Rico
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Rio Piedras
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San Juan
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Barcelona [Barcelona]
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Malaga
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
participants virologically suppressed on a regimen of bictegravir/emtricitabine/tenofovir
alafenamide (BIC/FTC/TAF). The primary hypothesis is that a switch to MK-8591A will be
non-inferior to continued treatment with BIC/FTC/TAF as assessed by the proportion of
participants with HIV-1 ribonucleic acid (RNA) =50 copies/mL at Week 48. Participants who
benefit from their assigned intervention (as determined by investigator) will be able to
continue treatment through a 24-week study extension.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04223791
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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0
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Phone
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0
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04223791
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