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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05766501




Registration number
NCT05766501
Ethics application status
Date submitted
1/03/2023
Date registered
13/03/2023
Date last updated
3/09/2024

Titles & IDs
Public title
A Study of Doravirine/Islatravir (DOR/ISL, MK-8591A) for the Treatment of Human Immunodeficiency Virus 1 (HIV-1) Infection in Participants Who Previously Received DOR/ISL (MK-8591A-054)
Scientific title
A Phase 3 Open-label Clinical Study of Doravirine/Islatravir (DOR/ISL [100 mg/0.25 mg]) Once Daily for the Treatment of HIV-1 Infection in Participants Who Previously Received DOR/ISL (100 mg/0.75 mg) QD in a Phase 3 Clinical Study
Secondary ID [1] 0 0
MK-8591A-054
Secondary ID [2] 0 0
8591A-054
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 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 - DOR/ISL

Experimental: DOR/ISL - Participants will receive fixed dose combination (FDC) tablet of DOR/ISL (100 mg/0.25 mg) taken once daily (QD) orally from Day 1 to Week 96. After Week 96, eligible participants may continue on DOR/ISL until week 240 or until DOR/ISL becomes commercially accessible, whichever comes first.


Treatment: Drugs: DOR/ISL
FDC tablet of 100 mg doravirine (DOR)/0.25 mg islatravir (ISL) taken once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with One or More Adverse Event (AE)
Timepoint [1] 0 0
Up to 102 Weeks
Primary outcome [2] 0 0
Percentage of participants who Discontinue Study Intervention Due to an AE
Timepoint [2] 0 0
Up to 96 Weeks
Secondary outcome [1] 0 0
Percentage of Participants with HIV-1 Ribonucleic Acid (RNA) =50 copies/mL at Week 96
Timepoint [1] 0 0
Week 96
Secondary outcome [2] 0 0
Percentage of Participants with HIV-1 RNA <50 copies/mL at Week 96
Timepoint [2] 0 0
Week 96
Secondary outcome [3] 0 0
Percentage of Participants with HIV-1 RNA <200 copies/mL at Week 96
Timepoint [3] 0 0
Week 96
Secondary outcome [4] 0 0
Percentage of Participants with Evidence of Viral Drug Resistance-Associated Substitutions
Timepoint [4] 0 0
Up to Week 96

Eligibility
Key inclusion criteria
* Is currently receiving doravirine/islatravir (DOR/ISL) adult fixed dose combination (FDC) tablet in Merck Sharp & Dohme (MSD)-sponsored clinical studies (MK-8591A-017, -018, -020, and -033 [except for heavily treatment-experienced (HTE) participants]).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has confirmed HIV-1 RNA =200 copies/mL in MSD DOR/ISL (100 mg/0.75 mg) MK-8591A-017 /-018 /-020, or at screening for participants entering from DOR/ISL (100 mg/0.75 mg) MK-8591A-033.
* Has confirmatory laboratory findings for cluster of differentiation 4+ (CD4+) T-cell counts or lymphocyte counts in the prior DOR/ISL study that meet criteria for discontinuation of DOR/ISL.
* Is a HTE participant receiving treatment in MK-8591A-019 or -033.

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
17/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/09/2028
Actual
Sample size
Target
650
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice ( Site 1100) - Darlinghurst
Recruitment hospital [2] 0 0
St Vincent's Hospital-IBAC ( Site 1103) - Sydney
Recruitment hospital [3] 0 0
Holdsworth House Medical Practice - Brisbane ( Site 1101) - Brisbane
Recruitment hospital [4] 0 0
Prahran Market Clinic ( Site 1102) - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
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
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Argentina
State/province [13] 0 0
Cordoba
Country [14] 0 0
Argentina
State/province [14] 0 0
Santa Fe
Country [15] 0 0
Argentina
State/province [15] 0 0
Buenos Aires
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Chile
State/province [18] 0 0
Araucania
Country [19] 0 0
Chile
State/province [19] 0 0
Maule
Country [20] 0 0
Chile
State/province [20] 0 0
Region M. De Santiago
Country [21] 0 0
Colombia
State/province [21] 0 0
Distrito Capital De Bogota
Country [22] 0 0
Colombia
State/province [22] 0 0
Valle Del Cauca
Country [23] 0 0
Israel
State/province [23] 0 0
Haifa
Country [24] 0 0
Israel
State/province [24] 0 0
Jerusalem
Country [25] 0 0
Israel
State/province [25] 0 0
Ramat Gan
Country [26] 0 0
Israel
State/province [26] 0 0
Tel Aviv
Country [27] 0 0
Japan
State/province [27] 0 0
Aichi
Country [28] 0 0
Japan
State/province [28] 0 0
Tokyo
Country [29] 0 0
Japan
State/province [29] 0 0
Osaka
Country [30] 0 0
New Zealand
State/province [30] 0 0
Canterbury
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
San Juan
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Kemerovskaya Oblast
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Krasnoyarskiy Kray
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Leningradskaya Oblast
Country [35] 0 0
Russian Federation
State/province [35] 0 0
Moskva
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Sankt-Peterburg
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Tatarstan, Respublika
Country [38] 0 0
South Africa
State/province [38] 0 0
Free State
Country [39] 0 0
South Africa
State/province [39] 0 0
Gauteng
Country [40] 0 0
South Africa
State/province [40] 0 0
Kwazulu-Natal
Country [41] 0 0
South Africa
State/province [41] 0 0
Western Cape
Country [42] 0 0
Switzerland
State/province [42] 0 0
Basel-Stadt
Country [43] 0 0
Switzerland
State/province [43] 0 0
Geneve
Country [44] 0 0
Switzerland
State/province [44] 0 0
Sankt Gallen
Country [45] 0 0
Switzerland
State/province [45] 0 0
Ticino
Country [46] 0 0
Switzerland
State/province [46] 0 0
Zurich
Country [47] 0 0
Switzerland
State/province [47] 0 0
Berne
Country [48] 0 0
Taiwan
State/province [48] 0 0
Kaohsiung
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Brighton And Hove
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Bristol, City Of
Country [51] 0 0
United Kingdom
State/province [51] 0 0
England
Country [52] 0 0
United Kingdom
State/province [52] 0 0
London, City Of
Country [53] 0 0
United Kingdom
State/province [53] 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
The purpose of this study is to evaluate the safety and tolerability of DOR/ISL in adult participants with HIV-1 who had been previously treated with DOR/ISL in earlier clinical studies. There are no formal hypotheses to be tested in this study.
Trial website
https://clinicaltrials.gov/study/NCT05766501
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05766501