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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04776252




Registration number
NCT04776252
Ethics application status
Date submitted
26/02/2021
Date registered
1/03/2021

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)
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
Secondary ID [1] 0 0
MK-8591A-033
Secondary ID [2] 0 0
8591A-033
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV-1 Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Participants with serious adverse events (SAEs)
Timepoint [1] 0 0
Up to Week 198
Primary outcome [2] 0 0
Participants who discontinued due to an adverse event (AE)
Timepoint [2] 0 0
Up to Week 192

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Is taking or is anticipated to require any prohibited therapies.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/10/2027
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice ( Site 0700) - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital-IBAC ( Site 0702) - Sydney
Recruitment hospital [3] 0 0
Fiona Stanley Hospital ( Site 0706) - Murdock
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
6150 - Murdock
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Ontario
Country [15] 0 0
Canada
State/province [15] 0 0
Quebec
Country [16] 0 0
Chile
State/province [16] 0 0
Araucania
Country [17] 0 0
Chile
State/province [17] 0 0
Region M. De Santiago
Country [18] 0 0
Colombia
State/province [18] 0 0
Valle Del Cauca
Country [19] 0 0
France
State/province [19] 0 0
Alpes-Maritimes
Country [20] 0 0
France
State/province [20] 0 0
Bourgogne
Country [21] 0 0
France
State/province [21] 0 0
Gironde
Country [22] 0 0
France
State/province [22] 0 0
Haute-Garonne
Country [23] 0 0
France
State/province [23] 0 0
Haute-Normandie
Country [24] 0 0
France
State/province [24] 0 0
Herault
Country [25] 0 0
France
State/province [25] 0 0
Ile-de-France
Country [26] 0 0
France
State/province [26] 0 0
Loire-Atlantique
Country [27] 0 0
France
State/province [27] 0 0
Nord
Country [28] 0 0
France
State/province [28] 0 0
Rhone
Country [29] 0 0
France
State/province [29] 0 0
Paris
Country [30] 0 0
Germany
State/province [30] 0 0
Niedersachsen
Country [31] 0 0
Italy
State/province [31] 0 0
Lazio
Country [32] 0 0
Italy
State/province [32] 0 0
Lombardia
Country [33] 0 0
Italy
State/province [33] 0 0
Milano
Country [34] 0 0
Japan
State/province [34] 0 0
Aichi
Country [35] 0 0
Japan
State/province [35] 0 0
Tokyo
Country [36] 0 0
Japan
State/province [36] 0 0
Osaka
Country [37] 0 0
New Zealand
State/province [37] 0 0
Canterbury
Country [38] 0 0
Poland
State/province [38] 0 0
Dolnoslaskie
Country [39] 0 0
Poland
State/province [39] 0 0
Lodzkie
Country [40] 0 0
Poland
State/province [40] 0 0
Mazowieckie
Country [41] 0 0
Russian Federation
State/province [41] 0 0
Kemerovskaya Oblast
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Krasnoyarskiy Kray
Country [43] 0 0
Russian Federation
State/province [43] 0 0
Leningradskaya Oblast
Country [44] 0 0
Russian Federation
State/province [44] 0 0
Moskva
Country [45] 0 0
Russian Federation
State/province [45] 0 0
Sankt-Peterburg
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Smolenskaya Oblast
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Tatarstan, Respublika
Country [48] 0 0
South Africa
State/province [48] 0 0
Free State
Country [49] 0 0
South Africa
State/province [49] 0 0
Gauteng
Country [50] 0 0
South Africa
State/province [50] 0 0
Kwazulu-Natal
Country [51] 0 0
South Africa
State/province [51] 0 0
Western Cape
Country [52] 0 0
Spain
State/province [52] 0 0
Alicante
Country [53] 0 0
Spain
State/province [53] 0 0
Barcelona
Country [54] 0 0
Spain
State/province [54] 0 0
Cataluna
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid, Comunidad De
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Switzerland
State/province [57] 0 0
Aargau
Country [58] 0 0
Switzerland
State/province [58] 0 0
Geneve
Country [59] 0 0
Switzerland
State/province [59] 0 0
Sankt Gallen
Country [60] 0 0
Switzerland
State/province [60] 0 0
Ticino
Country [61] 0 0
Switzerland
State/province [61] 0 0
Zurich
Country [62] 0 0
Switzerland
State/province [62] 0 0
Berne
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Brighton And Hove
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Bristol, City Of
Country [65] 0 0
United Kingdom
State/province [65] 0 0
England
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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/NCT04776252