Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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.


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
NA
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
14/01/2026
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
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/NCT05766501