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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
22/06/2025
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)
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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
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Secondary ID [1]
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MK-8591B-060
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Secondary ID [2]
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8591B-060
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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:
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
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Condition category
Condition code
Infection
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Acquired immune deficiency syndrome (AIDS / HIV)
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Intervention/exposure
Study type
Interventional
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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.
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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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Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 24
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Assessment method [1]
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Plasma HIV-1 ribonucleic acid (RNA) quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA =50 copies/mL will be reported at week 24.
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Timepoint [1]
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Week 24
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Primary outcome [2]
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Percentage of Participants who Experience an Adverse Event (AE)
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience an AE will be reported.
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Timepoint [2]
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Up to ~ 96 weeks
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Primary outcome [3]
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Percentage of Participants Discontinuing Study Treatment due to AEs
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who discontinue study treatment due to an AE will be reported.
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Timepoint [3]
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Up to ~ 96 weeks
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Secondary outcome [1]
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Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 48
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Assessment method [1]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a polymerase chain reaction (PCR) assay. Percentage of participants with HIV-1 RNA =50 copies/mL will be reported at week 48.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 24
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Assessment method [2]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 24.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 48
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Assessment method [3]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 48.
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Timepoint [3]
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Week 48
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Secondary outcome [4]
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Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 24
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Assessment method [4]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 24.
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 48
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Assessment method [5]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 48.
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Timepoint [5]
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Week 48
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Secondary outcome [6]
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Percentage of Participants With HIV-1 RNA =50 copies/mL at Week 96
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Assessment method [6]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA =50 copies/mL will be reported at week 96.
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Timepoint [6]
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Week 96
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Secondary outcome [7]
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Percentage of Participants With HIV-1 RNA <50 copies/mL at Week 96
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Assessment method [7]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<50 copies/mL will be reported at week 96.
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Timepoint [7]
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Week 96
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Secondary outcome [8]
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Percentage of Participants With HIV-1 RNA <200 copies/mL at Week 96
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Assessment method [8]
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Plasma HIV-1 RNA quantification will be performed at the central laboratory using a PCR assay. Percentage of participants with HIV-1 RNA \<200 copies/mL will be reported at week 96.
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Timepoint [8]
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Week 96
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Secondary outcome [9]
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Mean Change From Baseline in CD4+ T-cell Count at Week 24
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Assessment method [9]
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The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 24 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.
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Timepoint [9]
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Week 24
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Secondary outcome [10]
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Mean Change From Baseline in CD4+ T-cell Count at Week 48
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Assessment method [10]
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The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 48 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.
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Timepoint [10]
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Week 48
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Secondary outcome [11]
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Mean Change From Baseline in CD4+ T-cell Count at Week 96
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Assessment method [11]
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The mean change from baseline in CD4+ T-cell count will be calculated at each applicable time point at which CD4+ T-cell count is collected with primary interest at 96 weeks. Blood samples are taken for this purpose. Baseline measurements are defined as the Day 1 value for each participant.
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Timepoint [11]
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Week 96
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Secondary outcome [12]
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Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 24
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Assessment method [12]
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Antiviral drug resistance is the reduced susceptibility of the virus to the study intervention. Participants with HIV-1 RNA =400 copies/mL will be included in the resistance analyses. Participants who have test results showing signs of viral resistance will also be included for analysis, irrespective of the viral load. Percentage of participants in each treatment group who have evidence of resistance-associated substitutions will be analyzed at week 24.
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Timepoint [12]
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Week 24
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Secondary outcome [13]
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Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 48
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Assessment method [13]
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Antiviral drug resistance is the reduced susceptibility of the virus to the study intervention. Participants with HIV-1 RNA =400 copies/mL will be included in the resistance analyses. Participants who have test results showing signs of viral resistance will also be included for analysis, irrespective of the viral load. Percentage of participants in each treatment group who have evidence of resistance-associated substitutions will be analyzed at week 48.
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Timepoint [13]
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Week 48
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Secondary outcome [14]
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Percentage of Participants With Development of Viral Drug Resistance to any Component of Study Intervention at Week 96
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Assessment method [14]
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Antiviral drug resistance is the reduced susceptibility of the virus to the study intervention. Participants with HIV-1 RNA =400 copies/mL will be included in the resistance analyses. Participants who have test results showing signs of viral resistance will also be included for analysis, irrespective of the viral load. Percentage of participants in each treatment group who have evidence of resistance-associated substitutions will be analyzed at week 96.
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Timepoint [14]
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Week 96
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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.
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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
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
14/04/2025
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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
24/09/2027
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Actual
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Sample size
Target
150
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Momentum Clinical Research - Darlinghurst ( Site 4260) - Darlinghurst
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Recruitment hospital [2]
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St. Vincent's Hospital ( Site 4263) - Darlinghurst
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Recruitment hospital [3]
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Momentum Clinical Research Fortitude Valley ( Site 4261) - Fortitude Valley
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Recruitment hospital [4]
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The Alfred Hospital ( Site 4264) - Melbourne
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Recruitment hospital [5]
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Prahran Market Clinic ( Site 4262) - Prahran
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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4006 - Fortitude Valley
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Recruitment postcode(s) [3]
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3004 - Melbourne
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Recruitment postcode(s) [4]
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3181 - Prahran
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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District of Columbia
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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United States of America
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State/province [5]
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Missouri
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Country [6]
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United States of America
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State/province [6]
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North Carolina
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Country [7]
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United States of America
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State/province [7]
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Texas
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Country [8]
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Puerto Rico
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State/province [8]
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Ponce
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Country [9]
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Puerto Rico
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State/province [9]
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San Juan
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Country [10]
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Switzerland
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State/province [10]
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Basel-Stadt
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Country [11]
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Switzerland
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State/province [11]
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Berne
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Country [12]
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Switzerland
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State/province [12]
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Geneve
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Country [13]
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Switzerland
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State/province [13]
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Ticino
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Investigators are trying to find better treatments for people with HIV-1. In this clinical study, investigators want to see how well a new treatment called ISL+ULO, taken once a week, works compared to an existing treatment called BIC/FTC/TAF, which is taken every day. Investigators will check how many people still have a high level of the virus in their blood after 24 weeks. The investigators also want to understand if the new treatment, MK-8591B, is safe and how well people can handle it.
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Trial website
https://clinicaltrials.gov/study/NCT06891066
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
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
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