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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06891066




Registration number
NCT06891066
Ethics application status
Date submitted
17/03/2025
Date registered
24/03/2025
Date last updated
13/05/2025

Titles & IDs
Public title
A Study of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly (QW) in Virologically Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8591B-060)
Scientific title
A Phase 2b, Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Islatravir (ISL) and Ulonivirine (ULO) Once Weekly in Adults With HIV-1 Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily
Secondary ID [1] 0 0
MK-8591B-060
Secondary ID [2] 0 0
8591B-060
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus Type 1 (HIV-1) Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ISL
Treatment: Drugs - ULO
Treatment: Drugs - BIC/FTC/TAF

Experimental: ISL + ULO in Group 1 - In part 1 of the study, participants will receive ISL 2mg + ULO 200mg orally once a week (QW) for 48 weeks. In part 2 (2nd 48 weeks), participants will continue to receive ISL 2mg + ULO 200mg once a week till week 96.

Active comparator: BIC/FTC/TAF in Group 2 - In part 1 of the study, participants will receive BIC 50mg/FTC 200mg/TAF 25mg orally once daily (QD) for 48 weeks.

Experimental: ISL + ULO in Group 2 - In part 2 of the study, participants previously on BIC/FTC/TAF (for the 1st 48 weeks, or part 1) will switch to ISL + ULO, to week 96.


Treatment: Drugs: ISL
ISL 1mg oral capsule will be administered as 2mg orally (each capsule 1mg) as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.

Treatment: Drugs: ULO
ULO 100mg oral tablet will be administered as 200mg (2 tablets) orally as part of ISL and ULO combination to group 1 participants for 96 weeks and for group 2 participants in part 2 of the study from 49 to 96 weeks.

Treatment: Drugs: BIC/FTC/TAF
BIC 50mg oral tablet/FTC 200mg oral tablet/TAF 25 mg oral tablet administered orally to group 2 participants for 48 weeks in part 1 of the study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 24
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of Participants who Experience an Adverse Event (AE)
Timepoint [2] 0 0
Up to ~ 96 weeks
Primary outcome [3] 0 0
Percentage of Participants Discontinuing Study Treatment due to AEs
Timepoint [3] 0 0
Up to ~ 96 weeks
Secondary outcome [1] 0 0
Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 48
Timepoint [1] 0 0
Week 48
Secondary outcome [2] 0 0
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48
Timepoint [3] 0 0
Week 48
Secondary outcome [4] 0 0
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48
Timepoint [5] 0 0
Week 48
Secondary outcome [6] 0 0
Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 96
Timepoint [6] 0 0
Week 96
Secondary outcome [7] 0 0
Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96
Timepoint [7] 0 0
Week 96
Secondary outcome [8] 0 0
Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96
Timepoint [8] 0 0
Week 96
Secondary outcome [9] 0 0
Mean Change From Baseline in CD4+ T-cell Count at Week 24
Timepoint [9] 0 0
Week 24
Secondary outcome [10] 0 0
Mean Change From Baseline in CD4+ T-cell Count at Week 48
Timepoint [10] 0 0
Week 48
Secondary outcome [11] 0 0
Mean Change From Baseline in CD4+ T-cell Count at Week 96
Timepoint [11] 0 0
Week 96
Secondary outcome [12] 0 0
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24
Timepoint [12] 0 0
Week 24
Secondary outcome [13] 0 0
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48
Timepoint [13] 0 0
Week 48
Secondary outcome [14] 0 0
Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96
Timepoint [14] 0 0
Week 96

Eligibility
Key inclusion criteria
Inclusion:

The main inclusion criteria include but are not limited to the following:

- Has been receiving Bictegravir/Emtricitabine/Tenofovir alafenamide (BIC/FTC/TAF) therapy with documented viral suppression [Human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) <50 copies/mL] for =6 months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion:

The main exclusion criteria include but are not limited to the following:

* Has Human immunodeficiency virus type 2 (HIV-2) infection.
* Has a diagnosis of an active Acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.
* Has active hepatitis C virus (HCV) coinfection.
* Has hepatitis B virus (HBV) coinfection.
* Has a history of malignancy =5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.
* Has prior exposure to Islatravir (ISL) or Ulonivirine (ULO) for any duration any time prior to Day 1.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/09/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Momentum Clinical Research - Darlinghurst ( Site 4260) - Darlinghurst
Recruitment hospital [2] 0 0
Momentum Clinical Research Fortitude Valley ( Site 4261) - Fortitude Valley
Recruitment hospital [3] 0 0
Prahran Market Clinic ( Site 4262) - Prahran
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4006 - Fortitude Valley
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Missouri
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Puerto Rico
State/province [8] 0 0
Ponce
Country [9] 0 0
Puerto Rico
State/province [9] 0 0
San Juan
Country [10] 0 0
Switzerland
State/province [10] 0 0
Basel-Stadt
Country [11] 0 0
Switzerland
State/province [11] 0 0
Berne
Country [12] 0 0
Switzerland
State/province [12] 0 0
Geneve
Country [13] 0 0
Switzerland
State/province [13] 0 0
Ticino

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
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
[email protected]
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?
https://trialstransparency.msdclinicaltrials.com/pdf/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: https://externaldatasharing-msd.com/


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/NCT06891066