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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04223778
Registration number
NCT04223778
Ethics application status
Date submitted
8/01/2020
Date registered
10/01/2020
Date last updated
28/03/2024
Titles & IDs
Public title
Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)
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Scientific title
A Phase 3 Randomized, Active-Controlled, Open-Label Clinical Study to Evaluate a Switch to Doravirine/Islatravir (DOR/ISL) Once-Daily in Participants With HIV-1 Virologically Suppressed on Antiretroviral Therapy
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Secondary ID [1]
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MK-8591A-017
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Secondary ID [2]
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8591A-017
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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:
HIV 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 - DOR/ISL
Treatment: Drugs - ART
Experimental: Doravirine/Islatravir (DOR/ISL) - Participants who were previously treated with continuous background antiretroviral therapy (ART) will receive DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.
Active Comparator: Baseline Background Antiretroviral Therapy (ART) - Participants will receive continuous background ART for 48 weeks and DOR/ISL, a FDC of 100 mg DOR/0.75 mg ISL orally once daily for 48 weeks.
Treatment: Drugs: DOR/ISL
A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
Treatment: Drugs: ART
Baseline background ART regimen will be administered as per approved label. ART medication will not be provided by the Sponsor; participants will provide their own ART medications. Allowed drug classes include nucleoside analog reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transferase inhibitors (InSTIs), fusion inhibitors, chemokine receptor 5 (CCR5) antagonists, post-attachment inhibitor, and pharmacokinetic (PK) boosters.
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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 Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) =50 Copies/mL at Week 48
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Assessment method [1]
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HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA =50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
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Timepoint [1]
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Week 48
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Primary outcome [2]
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Percentage of Participants With One or More Adverse Events (AEs) up to Week 48
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Assessment method [2]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE was reported.
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Timepoint [2]
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Up to ~48 Weeks
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Primary outcome [3]
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Percentage of Participants Who Discontinued Study Intervention up to Week 48
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Assessment method [3]
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An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE was reported.
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Timepoint [3]
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Up to ~48 Weeks
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Secondary outcome [1]
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Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48
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Assessment method [1]
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HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA <40 copies/mL or <50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.
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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, <40 Copies/mL or <50 Copies/mL From Week 48 to Week 96
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Assessment method [2]
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HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA =50 copies/mL, <40 copies/mL, or <50 copies/mL from Week 48 to Week 96 will be presented using the FDA Snapshot missing data approach.
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Timepoint [2]
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Weeks 48-96 (up to ~48 weeks)
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Secondary outcome [3]
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Percentage of Participants With HIV-1 RNA =50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96
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Assessment method [3]
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HIV-1 RNA levels in blood samples taken at each visit will be measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA =50 copies/mL, <40 copies/mL, or <50 copies/mL at Week 96 will be presented using the FDA Snapshot missing data approach.
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Timepoint [3]
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Week 96
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Secondary outcome [4]
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Percentage Change From Baseline in CD4+ T-cell Count at Week 48
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Assessment method [4]
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Plasma CD4+ T-Cell Count was measured in cells/mm^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The percentage change from baseline to Week 48 is presented.
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Timepoint [4]
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Baseline and Week 48
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Secondary outcome [5]
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Percentage Change From Baseline in CD4+ T-cell Count at Week 96
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Assessment method [5]
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Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for baseline and 96 weeks. Baseline measurements will be defined as the Day 1 value of each participant. The percentage change from baseline to Week 96 will be presented.
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Timepoint [5]
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Baseline and Week 96
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Secondary outcome [6]
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Percentage Change From Week 48 in CD4+ T-cell Count at Week 96
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Assessment method [6]
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Plasma CD4+ T-Cell Count will be measured in cells/mm^3 for Week 48 and Week 96. The percentage change from Week 48 to Week 96 will be presented.
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Timepoint [6]
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Week 48 and Week 96
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Secondary outcome [7]
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Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48
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Assessment method [7]
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Viral drug resistance is defined as participants with confirmed HIV-1 RNA =400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrated drug resistance at Week 48 is presented.
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Timepoint [7]
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Week 48
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Secondary outcome [8]
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Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96
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Assessment method [8]
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Viral drug resistance is defined as participants with confirmed HIV-1 RNA =400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The number of participants who demonstrate drug resistance at Week 96 will be presented.
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Timepoint [8]
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Week 96
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Secondary outcome [9]
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Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
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Assessment method [9]
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Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
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Timepoint [9]
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Baseline and Week 24
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Secondary outcome [10]
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Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
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Assessment method [10]
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Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
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Timepoint [10]
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Baseline and Week 24
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Secondary outcome [11]
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Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
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Assessment method [11]
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Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.
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Timepoint [11]
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Baseline and Week 24
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Secondary outcome [12]
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Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens)
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Assessment method [12]
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Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
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Timepoint [12]
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Baseline and Week 48
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Secondary outcome [13]
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Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens)
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Assessment method [13]
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Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
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Timepoint [13]
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Baseline and Week 48
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Secondary outcome [14]
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Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens
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Assessment method [14]
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Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.
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Timepoint [14]
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Baseline and Week 48
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Secondary outcome [15]
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Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)
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Assessment method [15]
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Baseline measurements were defined as the Day 1 value of each participant. The change from baseline to Week 48 is presented for participants who received InSTI- based regimens.
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Timepoint [15]
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Baseline and Week 48
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Secondary outcome [16]
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Percentage of Participants With One or More AEs up to Week 96
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Assessment method [16]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
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Timepoint [16]
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Up to ~96 Weeks
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Secondary outcome [17]
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Percentage of Participants Who Discontinued Study Intervention up to Week 96
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Assessment method [17]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be reported.
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Timepoint [17]
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Up to ~96 Weeks
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Secondary outcome [18]
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Percentage of Participants With One or More AEs From Week 48 to Week 96
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Assessment method [18]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experience at least one AE will be reported.
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Timepoint [18]
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Weeks 48-96
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Secondary outcome [19]
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Percentage of Participants Who Discontinued Study Intervention From Week 48 to Week 96
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Assessment method [19]
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An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinue study intervention due to an AE will be reported.
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Timepoint [19]
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Weeks 48-96
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Eligibility
Key inclusion criteria
- Is HIV-1 positive
- Has been receiving continuous, stable oral 2-drug or 3-drug combination (±
pharmacokinetic (PK) booster) with documented viral suppression (HIV-1 RNA <50
copies/mL) for =3 months prior to signing informed consent and has no history of prior
virologic treatment failure on any past or current regimen.
- Female is eligible to participate if she is not pregnant or breastfeeding, and at
least one of the following conditions applies: is not a woman of childbearing
potential (WOCBP); is a WOCBP and using an acceptable contraceptive method, or be
abstinent from heterosexual intercourse as their preferred and usual lifestyle; a
WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as
required by local regulations) within 24 hours before the first dose of study
intervention; if a urine test cannot be confirmed as negative (e.g. an ambiguous
result), a serum pregnancy test is required. In such cases, the participant must be
excluded from participation if the serum pregnancy result is positive
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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
- Has HIV-2 infection
- Has hypersensitivity or other contraindication to any of the components of the study
interventions as determined by the investigator
- Has an active diagnosis of hepatitis due to any cause, including active Hepatitis B
Virus (HBV) co-infection
- Has a history of malignancy =5 years prior to signing informed consent except for
adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer,
or cutaneous Kaposi's sarcoma
- Is taking or is anticipated to require systemic immunosuppressive therapy, immune
modulators, or any prohibited therapies
- Is currently taking long-acting cabotegravir-rilpivirine
- Is currently participating in or has participated in a clinical study with an
investigational compound or device from 45 days prior to Day 1 through the study
treatment period
- Has a documented or known virologic resistance to DOR
- Female expects to conceive or donate eggs at any time during the study
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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 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not 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
18/02/2020
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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
22/11/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
672
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Holdsworth House Medical Practice ( Site 2300) - Sydney
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Recruitment hospital [2]
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Royal Brisbane and Womens Hospital- Infectious Diseases Unit ( Site 2309) - Herston
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Recruitment hospital [3]
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Melbourne Sexual Health Centre ( Site 2305) - Carlton
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Recruitment hospital [4]
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Fiona Stanley Hospital ( Site 2301) - Murdoch
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3053 - Carlton
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Recruitment postcode(s) [4]
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6150 - Murdoch
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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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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Missouri
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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0
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Canada
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State/province [10]
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Alberta
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0
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Canada
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State/province [11]
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British Columbia
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0
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Canada
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State/province [12]
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Ontario
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Country [13]
0
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Canada
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Quebec
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Country [14]
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Chile
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State/province [14]
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Araucania
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Chile
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State/province [15]
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Region Metropolitana De Santiago
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Country [16]
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Colombia
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State/province [16]
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Valle Del Cauca
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France
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Cote-d'Or
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France
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Gironde
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France
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Haute-Garonne
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France
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Loire-Atlantique
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France
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Rhone-Alpes
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France
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Seine-Maritime
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France
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Paris
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Italy
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Milano
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Italy
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Napoli
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0
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Italy
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Roma
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0
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Japan
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0
0
Aichi
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0
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Japan
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0
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Osaka
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0
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Japan
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Tokyo
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0
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New Zealand
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Canterbury
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Poland
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Dolnoslaskie
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Poland
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Lodzkie
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Poland
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Mazowieckie
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Poland
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Wroclaw
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Russian Federation
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Kemerovskaya Oblast'
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Russian Federation
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Krasnoyarskiy Kray
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Russian Federation
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Leningradskaya Oblast'
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Russian Federation
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Moskva
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Sverdlovskaya Oblast'
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Russian Federation
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State/province [41]
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Tatarstan, Respublika
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0
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South Africa
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Free State
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South Africa
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Western Cape
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Spain
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Alicante
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Spain
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Barcelona [Barcelona]
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Basel-Stadt
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Switzerland
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Berne
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Switzerland
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Geneve
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Switzerland
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Sankt Gallen
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0
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Switzerland
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Ticino
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Switzerland
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Zurich
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United Kingdom
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Brighton And Hove
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0
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United Kingdom
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State/province [55]
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Bristol, City Of
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0
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United Kingdom
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State/province [56]
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Camden
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0
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United Kingdom
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London, City Of
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Country [58]
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United Kingdom
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State/province [58]
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Manchester
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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
This study will evaluate the safety and efficacy of a switch to MK-8591A (a fixed dose
combination of doravirine and islatravir) in human immunodeficiency virus -1 (HIV-1)-infected
participants virologically suppressed on a protocol-specified background antiretroviral
regimen. The primary hypothesis is that a switch to MK-8591A will be non-inferior to
continued treatment with baseline antiretroviral therapy (ART) as assessed by the percentage
of participants with HIV-1 ribonucleic acid (RNA) =50 copies/mL at Week 48.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04223778
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Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04223778
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