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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/NCT04776252
Registration number
NCT04776252
Ethics application status
Date submitted
26/02/2021
Date registered
1/03/2021
Date last updated
2/04/2024
Titles & IDs
Public title
Open-label, Follow-up of Doravirine/Islatravir (DOR/ISL 100 mg/0.75mg) for Participants With Human Immunodeficiency Virus-1 (HIV-1) Infection (MK-8591A-033)
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Scientific title
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
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Secondary ID [1]
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MK-8591A-033
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Secondary ID [2]
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8591A-033
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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
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MK-8591A
Experimental: MK-8591A - Fixed dose combination (FDC) tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks.
Treatment: Drugs: MK-8591A
FDC tablet of 100 mg doravirine, 0.75 mg islatravir taken orally, once daily for up to 192 weeks
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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 serious adverse events (SAEs)
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Assessment method [1]
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Percentage of participants with serious adverse events (SAEs)
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Timepoint [1]
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Up to Week 198
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Primary outcome [2]
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Participants who discontinued due to an adverse event (AE)
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Assessment method [2]
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Percentage of participants who discontinued study treatment due to an AE.
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Timepoint [2]
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Up to Week 192
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Eligibility
Key inclusion criteria
- Is currently receiving DOR 100 mg/ISL 0.75 mg adult 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)
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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
- Is taking or is anticipated to require any prohibited therapies.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
15/09/2021
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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
15/10/2027
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Holdsworth House Medical Practice ( Site 0700) - Darlinghurst
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Recruitment hospital [2]
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St Vincent's Hospital-IBAC ( Site 0702) - Sydney
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Recruitment hospital [3]
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Fiona Stanley Hospital ( Site 0706) - Murdock
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2010 - Darlinghurst
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2010 - Sydney
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Recruitment postcode(s) [3]
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6150 - Murdock
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Recruitment outside Australia
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Manchester
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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
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Summary
Brief summary
The safety and tolerability of MK-8591A, a 2-drug fixed dose combination (FDC) of doravirine
(DOR 100mg) and islatravir (ISL 0.75mg) will be evaluated in participants with Human
Immunodeficiency Virus -1 (HIV-1) who were treated with DOR and ISL in earlier clinical
studies.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04776252
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Trial related presentations / publications
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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 scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04776252
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