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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/NCT04233216
Registration number
NCT04233216
Ethics application status
Date submitted
15/01/2020
Date registered
18/01/2020
Date last updated
8/12/2023
Titles & IDs
Public title
Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)
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Scientific title
A Phase 3, Randomized, Clinical Study in HIV-1-Infected Heavily Treatment-Experienced Participants Evaluating the Antiretroviral Activity of Blinded Islatravir (ISL), Doravirine (DOR), and Doravirine/Islatravir (DOR/ISL), Each Compared to Placebo, and the Antiretroviral Activity, Safety, and Tolerability of Open-Label DOR/ISL
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Secondary ID [1]
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MK-8591A-019
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Secondary ID [2]
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8591A-019
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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-1 Infection
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Condition category
Condition code
Infection
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0
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Studies of infection and infectious agents
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Infection
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ISL
Treatment: Drugs - DOR
Treatment: Drugs - DOR/ISL
Treatment: Drugs - Placebo to ISL
Treatment: Drugs - Placebo to DOR
Experimental: ISL + ART - HTE participants with HIV-1 infection take ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97.
Experimental: DOR + ART - HTE participants with HIV-1 infection take DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Experimental: DOR/ISL + ART - HTE participants with HIV-1 infection take 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Placebo Comparator: Placebo + ART - HTE participants with HIV-1 infection take placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97.
Treatment: Drugs: ISL
ISL 0.75 mg capsule taken by mouth.
Treatment: Drugs: DOR
DOR 100 mg tablet taken by mouth.
Treatment: Drugs: DOR/ISL
100 mg DOR/0.75 mg ISL FDC taken by mouth.
Treatment: Drugs: Placebo to ISL
Placebo capsule matched to ISL taken by mouth.
Treatment: Drugs: Placebo to DOR
Placebo tablet matched to DOR taken by mouth.
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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 Receiving Doravirine/Islatravir (DOR/ISL) With =0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment
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Assessment method [1]
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Participants with a =0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure.
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Timepoint [1]
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Day 1 (baseline) and Day 8
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Primary outcome [2]
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Percentage of Participants With =1 AEs Through Week 49
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Timepoint [2]
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Up to 49 weeks
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Primary outcome [3]
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Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25
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Assessment method [3]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Timepoint [3]
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Up to 25 weeks
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Primary outcome [4]
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Percentage of Participants With =1 Adverse Events (AEs) Through Week 25
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Assessment method [4]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Timepoint [4]
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Up to 25 weeks
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Primary outcome [5]
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Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49
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Assessment method [5]
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
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Timepoint [5]
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Up to 49 weeks
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Secondary outcome [1]
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Percentage of Participants With =1 Adverse Events (AEs) Through Week 97
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Assessment method [1]
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An AE is 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.
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Timepoint [1]
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Up to 97 weeks
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Secondary outcome [2]
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Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97
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Assessment method [2]
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An AE is 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.
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Timepoint [2]
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Up to 97 weeks
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Secondary outcome [3]
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Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With =0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
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Assessment method [3]
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Participants with a =0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure. Participants treated with DOR/ISL FDC were not analyzed in this outcome measure.
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Timepoint [3]
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Day 1 (baseline) and Day 8
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Secondary outcome [4]
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Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment
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Assessment method [4]
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The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution.
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Timepoint [4]
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Day 1 (baseline) and Day 8
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Secondary outcome [5]
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Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With =1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment
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Assessment method [5]
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Participants with a =1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL
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Timepoint [5]
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Day 1 (baseline) and Day 8
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Secondary outcome [6]
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Percentage of Participants Receiving DOR/ISL (Given With ART) With =0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
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Assessment method [6]
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Participants with a =0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure.
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Timepoint [6]
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Day 1 (baseline) and Day 8
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Secondary outcome [7]
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Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment
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Assessment method [7]
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The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the t-distribution. The group treated with placebo were not analyzed in this outcome measure.
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Timepoint [7]
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Day 1 (baseline) and Day 8
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Secondary outcome [8]
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Percentage of Participants Receiving DOR/ISL (Given With ART) With =1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment
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Assessment method [8]
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Participants receiving DOR/ISL with a =1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure.
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Timepoint [8]
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Day 1 (baseline) and Day 8
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Secondary outcome [9]
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Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
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Assessment method [9]
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The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [9]
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Day 1 (baseline) and Week 25
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Secondary outcome [10]
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Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
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Assessment method [10]
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The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [10]
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Day 1 (baseline) and Week 49
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Secondary outcome [11]
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Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
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Assessment method [11]
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0
The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [11]
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0
Day 1 (baseline) and Week 97
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Secondary outcome [12]
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0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
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Assessment method [12]
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0
The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [12]
0
0
Day 8 (baseline) and Week 25
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Secondary outcome [13]
0
0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
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Assessment method [13]
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0
The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [13]
0
0
Day 8 (baseline) and Week 49
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Secondary outcome [14]
0
0
Percentage of Participants From the Pooled Treatment Group With =0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
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Assessment method [14]
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0
The percentage of participants in the pooled treatment group with =0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [14]
0
0
Day 8 (baseline) and Week 97
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Secondary outcome [15]
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Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA
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Assessment method [15]
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The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [15]
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Day 1 (baseline) and Week 25
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Secondary outcome [16]
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0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA
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Assessment method [16]
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0
The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [16]
0
0
Day 1 (baseline) and Week 49
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Secondary outcome [17]
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0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA
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Assessment method [17]
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0
The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [17]
0
0
Day 1 (baseline) and Week 97
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Secondary outcome [18]
0
0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA
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Assessment method [18]
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0
The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [18]
0
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Day 8 (baseline) and Week 25
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Secondary outcome [19]
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0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA
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Assessment method [19]
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0
The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [19]
0
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Day 8 (baseline) and Week 49
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Secondary outcome [20]
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0
Percentage of Participants From the Pooled Treatment Group With =1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA
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Assessment method [20]
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The percentage of participants in the pooled treatment group with =1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [20]
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Day 8 (baseline) and Week 97
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Secondary outcome [21]
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Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [21]
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The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [21]
0
0
Day 1 (baseline) and Week 25
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Secondary outcome [22]
0
0
Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [22]
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0
The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [22]
0
0
Day 1 (baseline) and Week 49
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Secondary outcome [23]
0
0
Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [23]
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0
The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [23]
0
0
Day 1 (baseline) and Week 97
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Secondary outcome [24]
0
0
Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [24]
0
0
The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [24]
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0
Day 8 (baseline) and Week 25
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Secondary outcome [25]
0
0
Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [25]
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0
The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [25]
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0
Day 8 (baseline) and Week 49
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Secondary outcome [26]
0
0
Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group
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Assessment method [26]
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The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [26]
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0
Day 8 (baseline) and Week 97
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Secondary outcome [27]
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Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL
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Assessment method [27]
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The percentage of participants with HIV-1 RNA <200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
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Timepoint [27]
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0
Day 1 (baseline) and Day 8
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Secondary outcome [28]
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Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL
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Assessment method [28]
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The percentage of participants with HIV-1 RNA <50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
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Timepoint [28]
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0
Day 1 (baseline) and Day 8
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Secondary outcome [29]
0
0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL
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Assessment method [29]
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The percentage of participants with HIV-1 RNA <40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method.
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Timepoint [29]
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0
Day 1 (baseline) and Day 8
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Secondary outcome [30]
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0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25
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Assessment method [30]
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The percentage of participants with HIV-1 RNA <200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [30]
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0
Week 25
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Secondary outcome [31]
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0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49
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Assessment method [31]
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The percentage of participants with HIV-1 RNA <200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [31]
0
0
Week 49
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Secondary outcome [32]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97
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Assessment method [32]
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The percentage of participants with HIV-1 RNA <200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [32]
0
0
Week 97
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Secondary outcome [33]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25
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Assessment method [33]
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0
The percentage of participants with HIV-1 RNA <50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [33]
0
0
Week 25
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Secondary outcome [34]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49
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Assessment method [34]
0
0
The percentage of participants with HIV-1 RNA <50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [34]
0
0
Week 49
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Secondary outcome [35]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97
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Assessment method [35]
0
0
The percentage of participants with HIV-1 RNA <50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [35]
0
0
Week 97
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Secondary outcome [36]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25
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Assessment method [36]
0
0
The percentage of participants with HIV-1 RNA <40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [36]
0
0
Week 25
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Secondary outcome [37]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49
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Assessment method [37]
0
0
The percentage of participants with HIV-1 RNA <40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol.
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Timepoint [37]
0
0
Week 49
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Secondary outcome [38]
0
0
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97
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Assessment method [38]
0
0
The percentage of participants with HIV-1 RNA <40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol,
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Timepoint [38]
0
0
Week 97
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Secondary outcome [39]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25
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Assessment method [39]
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0
The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
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Timepoint [39]
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0
Week 25
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Secondary outcome [40]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49
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Assessment method [40]
0
0
The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Query!
Timepoint [40]
0
0
Week 49
Query!
Secondary outcome [41]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25
Query!
Assessment method [41]
0
0
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Query!
Timepoint [41]
0
0
Week 25
Query!
Secondary outcome [42]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49
Query!
Assessment method [42]
0
0
The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Query!
Timepoint [42]
0
0
Week 49
Query!
Secondary outcome [43]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25
Query!
Assessment method [43]
0
0
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Query!
Timepoint [43]
0
0
Week 25
Query!
Secondary outcome [44]
0
0
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49
Query!
Assessment method [44]
0
0
The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA =200 copies/mL Analysis of the pooled treatment group was planned per protocol.
Query!
Timepoint [44]
0
0
Week 49
Query!
Secondary outcome [45]
0
0
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25
Query!
Assessment method [45]
0
0
The number of participants from the pooled treatment group who had HIV-1 RNA =200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [45]
0
0
Week 25
Query!
Secondary outcome [46]
0
0
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49
Query!
Assessment method [46]
0
0
The number of participants from the pooled treatment group who had HIV-1 RNA =200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [46]
0
0
Week 49
Query!
Secondary outcome [47]
0
0
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97
Query!
Assessment method [47]
0
0
The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [47]
0
0
Week 97
Query!
Secondary outcome [48]
0
0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 25
Query!
Assessment method [48]
0
0
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA =200 copies/mL at Week 25 is presented. .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [48]
0
0
Week 25
Query!
Secondary outcome [49]
0
0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 49
Query!
Assessment method [49]
0
0
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA =200 copies/mL at Week 49 is presented. .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [49]
0
0
Week 49
Query!
Secondary outcome [50]
0
0
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA =200 Copies/mL at Week 97
Query!
Assessment method [50]
0
0
The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA =200 copies/mL at Week 97 is presented. .Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [50]
0
0
Week 97
Query!
Secondary outcome [51]
0
0
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [51]
0
0
The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [51]
0
0
Day 1 (baseline) and Week 25
Query!
Secondary outcome [52]
0
0
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [52]
0
0
The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [52]
0
0
Day 1 (baseline) and Week 49
Query!
Secondary outcome [53]
0
0
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [53]
0
0
The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [53]
0
0
Day 1 (baseline) and Week 97
Query!
Secondary outcome [54]
0
0
Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [54]
0
0
The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [54]
0
0
Day 8 (baseline) and Week 25
Query!
Secondary outcome [55]
0
0
Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [55]
0
0
The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [55]
0
0
Day 8 (baseline) and Week 49
Query!
Secondary outcome [56]
0
0
Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group
Query!
Assessment method [56]
0
0
The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol,
Query!
Timepoint [56]
0
0
Day 8 (baseline) and Week 97
Query!
Eligibility
Key inclusion criteria
- Is HIV-1 positive.
- Has been receiving the same baseline ART for =3 months prior to signing the Informed
Consent Form/Assent Form.
- Weighs =35 kg.
- Has at least triple-class resistance (must include nucleoside reverse transcriptase
inhibitor [NRTI], non-nucleoside reverse transcriptase inhibitor [NNRTI], and
resistance to either protease inhibitor (PI) or integrase strand transfer inhibitor
(InSTI), based on central laboratory-based resistance or proviral DNA resistance
testing at the Screening Visit, or historical resistance testing within 12 months of
screening.
- Has =2 fully active antiretroviral drugs remaining among all antiretroviral classes
that can be effectively combined to form a viable regimen based on resistance,
tolerability, safety, drug access, or acceptability to participant.
- If female, is not pregnant or breastfeeding, and is: 1) not a woman of childbearing
potential (WOCBP); 2) a WOCBP and uses an acceptable method of contraception/is
abstinent; or 3) a WOCBP and has a negative pregnancy test within 24 hours of the
first dose of study medication.
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Has HIV type 2 (HIV-2) infection.
- Has hypersensitivity or other contraindication to any of the components of the study
interventions as determined by the investigator.
- Has hepatitis B virus (HBV) co-infection (defined as hepatitis B surface antigen
[HBsAg]-positive or HBV deoxyribonucleic acid [DNA] positive) and is not currently
being treated for HBV.
- Has a history or current evidence of any condition, therapy (including active TB
co-infection), laboratory abnormality or other circumstance (including drug or alcohol
abuse or dependence) that might, in the opinion of the investigator, confound the
results of the study or interfere with study participation for the full study
duration.
- Is taking or is anticipated to require any of the prohibited therapies from the
Screening Visit and throughout the study treatment period.
- Is taking DOR as part of his/her current failing antiretroviral regimen.
- Is taking efavirenz (EFV), etravirine, or nevirapine.
- Is currently participating in or has participated in an interventional clinical study
with an investigational compound or device from the Screening Visit through the study
treatment period.
- Is female and is expecting to conceive or donate eggs at any time during the study.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/03/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/11/2023
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
35
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Query!
Recruitment hospital [1]
0
0
Holdsworth House Medical Practice ( Site 5300) - Sydney
Query!
Recruitment hospital [2]
0
0
St Vincent's Hospital ( Site 5309) - Sydney
Query!
Recruitment hospital [3]
0
0
Holdsworth House Medical Practice - Brisbane ( Site 5312) - Brisbane
Query!
Recruitment hospital [4]
0
0
Monash Health-Monash Medical Centre ( Site 5313) - Clayton
Query!
Recruitment hospital [5]
0
0
The Alfred Hospital ( Site 5304) - Melbourne
Query!
Recruitment postcode(s) [1]
0
0
2000 - Sydney
Query!
Recruitment postcode(s) [2]
0
0
2010 - Sydney
Query!
Recruitment postcode(s) [3]
0
0
4006 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [5]
0
0
3004 - Melbourne
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Connecticut
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Mississippi
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
New Jersey
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
North Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Washington
Query!
Country [15]
0
0
Canada
Query!
State/province [15]
0
0
British Columbia
Query!
Country [16]
0
0
Canada
Query!
State/province [16]
0
0
Ontario
Query!
Country [17]
0
0
Canada
Query!
State/province [17]
0
0
Quebec
Query!
Country [18]
0
0
Chile
Query!
State/province [18]
0
0
Araucania
Query!
Country [19]
0
0
Chile
Query!
State/province [19]
0
0
Region M. De Santiago
Query!
Country [20]
0
0
Colombia
Query!
State/province [20]
0
0
Distrito Capital De Bogota
Query!
Country [21]
0
0
Colombia
Query!
State/province [21]
0
0
Valle Del Cauca
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Ain
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Alpes-Maritimes
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Bouches-du-Rhone
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Gironde
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Haute-Normandie
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Herault
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Nord
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Seine-Saint-Denis
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Paris
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Niedersachsen
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Nordrhein-Westfalen
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Berlin
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Hamburg
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Emilia-Romagna
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Monza E Brianza
Query!
Country [37]
0
0
Italy
Query!
State/province [37]
0
0
Milano
Query!
Country [38]
0
0
Italy
Query!
State/province [38]
0
0
Pavia
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Roma
Query!
Country [40]
0
0
Japan
Query!
State/province [40]
0
0
Tokyo
Query!
Country [41]
0
0
Korea, Republic of
Query!
State/province [41]
0
0
Pusan-Kwangyokshi
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Seoul
Query!
Country [43]
0
0
Peru
Query!
State/province [43]
0
0
Muni Metro De Lima
Query!
Country [44]
0
0
Peru
Query!
State/province [44]
0
0
Lima
Query!
Country [45]
0
0
Portugal
Query!
State/province [45]
0
0
Braga
Query!
Country [46]
0
0
Portugal
Query!
State/province [46]
0
0
Lisboa
Query!
Country [47]
0
0
Portugal
Query!
State/province [47]
0
0
Porto
Query!
Country [48]
0
0
Puerto Rico
Query!
State/province [48]
0
0
San Juan
Query!
Country [49]
0
0
Russian Federation
Query!
State/province [49]
0
0
Leningradskaya Oblast
Query!
Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Moskva
Query!
Country [51]
0
0
Russian Federation
Query!
State/province [51]
0
0
Samarskaya Oblast
Query!
Country [52]
0
0
Russian Federation
Query!
State/province [52]
0
0
Sankt-Peterburg
Query!
Country [53]
0
0
Russian Federation
Query!
State/province [53]
0
0
Smolenskaya Oblast
Query!
Country [54]
0
0
Russian Federation
Query!
State/province [54]
0
0
Sverdlovskaya Oblast
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Tatarstan, Respublika
Query!
Country [56]
0
0
South Africa
Query!
State/province [56]
0
0
Free State
Query!
Country [57]
0
0
South Africa
Query!
State/province [57]
0
0
Gauteng
Query!
Country [58]
0
0
South Africa
Query!
State/province [58]
0
0
Kwazulu-Natal
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Barcelona
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Cataluna
Query!
Country [61]
0
0
Spain
Query!
State/province [61]
0
0
Murcia, Region De
Query!
Country [62]
0
0
Spain
Query!
State/province [62]
0
0
Madrid
Query!
Country [63]
0
0
Ukraine
Query!
State/province [63]
0
0
Dnipropetrovska Oblast
Query!
Country [64]
0
0
Ukraine
Query!
State/province [64]
0
0
Kharkivska Oblast
Query!
Country [65]
0
0
Ukraine
Query!
State/province [65]
0
0
Khersonska Oblast
Query!
Country [66]
0
0
Ukraine
Query!
State/province [66]
0
0
Kyivska Oblast
Query!
Country [67]
0
0
Ukraine
Query!
State/province [67]
0
0
Mykolaivska Oblast
Query!
Country [68]
0
0
Ukraine
Query!
State/province [68]
0
0
Odeska Oblast
Query!
Country [69]
0
0
Ukraine
Query!
State/province [69]
0
0
Vinnytska Oblast
Query!
Country [70]
0
0
Ukraine
Query!
State/province [70]
0
0
Kyiv
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
Camden
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Edinburgh, City Of
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This is a 2-part, phase 3 clinical study evaluating the antiretroviral activity and
safety/tolerability of islatravir (ISL), doravirine (DOR), and a fixed dose combination (FDC)
of DOR/ISL (also known as MK-8591A) in heavily treatment-experienced (HTE) participants with
human immunodeficiency virus type 1 (HIV-1) infection. It is hypothesized that the percentage
of participants receiving DOR/ISL to achieve =0.5 log10 decrease in HIV-1 ribonucleic acid
(RNA) from study baseline (Day 1) to Day 8 is superior to placebo, each given in combination
with failing antiretroviral therapy (ART).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04233216
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04233216
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