Trial Outcomes & Findings for Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019) (NCT NCT04233216)

Last Updated: 2024-12-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

Day 1 (baseline) and Day 8

Results posted on

2024-12-27

Participant Flow

Heavily Treatment-Experienced (HTE) adult participants with Human Immunodeficiency Virus Type 1 (HIV-1) infection and currently on failing antiretroviral therapy (ART) were enrolled in this study.

Participant milestones

Participant milestones
Measure	ISL + ART HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.	DOR + ART HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Overall Study STARTED	7	14	7	7
Overall Study COMPLETED	6	9	4	5
Overall Study NOT COMPLETED	1	5	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	ISL + ART HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.	DOR + ART HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Overall Study Lost to Follow-up	1	0	2	0
Overall Study Physician Decision	0	3	0	2
Overall Study Withdrawal by Subject	0	2	1	0

Baseline Characteristics

Doravirine/Islatravir (DOR/ISL) in Heavily Treatment-Experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.	Total n=35 Participants Total of all reporting groups
Age, Continuous	46.6 Years STANDARD_DEVIATION 12.7 • n=5 Participants	48.6 Years STANDARD_DEVIATION 11.8 • n=7 Participants	54.0 Years STANDARD_DEVIATION 10.0 • n=5 Participants	44.6 Years STANDARD_DEVIATION 9.1 • n=4 Participants	48.5 Years STANDARD_DEVIATION 11.1 • n=21 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	27 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	31 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	20 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Plasma HIV-1 RNA	4.1 Log10 copies/mL STANDARD_DEVIATION 0.8 • n=5 Participants	4.3 Log10 copies/mL STANDARD_DEVIATION 0.9 • n=7 Participants	4.5 Log10 copies/mL STANDARD_DEVIATION 0.8 • n=5 Participants	4.2 Log10 copies/mL STANDARD_DEVIATION 0.7 • n=4 Participants	4.3 Log10 copies/mL STANDARD_DEVIATION 0.8 • n=21 Participants
Custer of differentiation 4+ (CD4+) T-cell Count	166.3 cells/mm^3 STANDARD_DEVIATION 121.7 • n=5 Participants	132.4 cells/mm^3 STANDARD_DEVIATION 136.6 • n=7 Participants	178.6 cells/mm^3 STANDARD_DEVIATION 135.5 • n=5 Participants	132.6 cells/mm^3 STANDARD_DEVIATION 100.7 • n=4 Participants	148.5 cells/mm^3 STANDARD_DEVIATION 123.3 • n=21 Participants
Genotypic resistance Nucleos(t)ide reverse transcriptase inhibitor (NRTI) substitutions	7 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	35 Participants n=21 Participants
Genotypic resistance Non-nucleoside reverse transcriptase inhibitor (NNRTI) substitutions	7 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	35 Participants n=21 Participants
Genotypic resistance Protease inhibitor (PI) substitutions	7 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	35 Participants n=21 Participants
Genotypic resistance Integrase strand transfer inhibitor (InSTI )substitutions	5 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Phenotypic resistance NRTI	7 Participants n=5 Participants	14 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	35 Participants n=21 Participants
Phenotypic resistance NNRTI	6 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	33 Participants n=21 Participants
Phenotypic resistance PI	7 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	32 Participants n=21 Participants
Phenotypic resistance InSTI	5 Participants n=5 Participants	9 Participants n=7 Participants	5 Participants n=5 Participants	7 Participants n=4 Participants	26 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 1 (baseline) and Day 8

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
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	—	—	85.7 Percentage of participants Interval 42.1 to 99.6	0.0 Percentage of participants Interval 0.0 to 41.0

PRIMARY outcome

Timeframe: Up to 49 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants With ≥1 AEs Through Week 49	85.7 Percentage of participants	71.4 Percentage of participants	85.7 Percentage of participants	85.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 25 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25	7.1 Percentage of participants	0.0 Percentage of participants	14.3 Percentage of participants	0.0 Percentage of participants

PRIMARY outcome

Timeframe: Up to 25 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25	85.7 Percentage of participants	42.9 Percentage of participants	85.7 Percentage of participants	85.7 Percentage of participants

PRIMARY outcome

Timeframe: Up to 49 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49	14.3 Percentage of participants	0.0 Percentage of participants	14.3 Percentage of participants	0.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 97 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97	100.0 Percentage of participants	85.7 Percentage of participants	85.7 Percentage of participants	100.0 Percentage of participants

SECONDARY outcome

Timeframe: Up to 97 weeks

Population: All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97	21.4 Percentage of participants	0.0 Percentage of participants	28.6 Percentage of participants	14.3 Percentage of participants

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
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	78.6 Percentage of participants Interval 49.2 to 95.3	28.6 Percentage of participants Interval 3.7 to 71.0	—	0.0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
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	-0.96 Log10 Copies/mL Interval -1.38 to -0.54	-0.44 Log10 Copies/mL Interval -0.96 to 0.07	-1.23 Log10 Copies/mL Interval -1.72 to -0.75	0.03 Log10 Copies/mL Interval -0.15 to 0.21

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
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	50.0 Percentage of participants Interval 23.0 to 77.0	14.3 Percentage of participants Interval 0.4 to 57.9	85.7 Percentage of participants Interval 42.1 to 99.6	0.0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
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	78.6 Percentage of participants Interval 49.2 to 95.3	28.6 Percentage of participants Interval 3.7 to 71.0	85.7 Percentage of participants Interval 42.1 to 99.6	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
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	-0.96 Log10 Copies/mL Interval -1.38 to -0.54	-0.44 Log10 Copies/mL Interval -0.96 to 0.07	-1.23 Log10 Copies/mL Interval -1.72 to -0.75	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
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	50.0 Percentage of participants Interval 23.0 to 77.0	14.3 Percentage of participants Interval 0.4 to 57.9	85.7 Percentage of participants Interval 42.1 to 99.6	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 25

Population: Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA	—	85.3 Percentage of participants Interval 68.9 to 95.0	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA	—	80.6 Percentage of participants Interval 62.5 to 92.5	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA	—	84.6 Percentage of participants Interval 65.1 to 95.6	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA	—	64.7 Percentage of participants Interval 46.5 to 80.3	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA	—	67.7 Percentage of participants Interval 48.6 to 83.3	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA	—	69.2 Percentage of participants Interval 48.2 to 85.7	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA	—	67.6 Percentage of participants Interval 49.5 to 82.6	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA	—	71.0 Percentage of participants Interval 52.0 to 85.8	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA	—	73.1 Percentage of participants Interval 52.2 to 88.4	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA	—	58.8 Percentage of participants Interval 40.7 to 75.4	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA	—	61.3 Percentage of participants Interval 42.2 to 78.2	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA	—	61.5 Percentage of participants Interval 40.6 to 79.8	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group	—	-1.89 Log10 Copies/mL Interval -2.33 to -1.45	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group	—	-2.00 Log10 Copies/mL Interval -2.47 to -1.53	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group	—	-2.01 Log10 Copies/mL Interval -2.51 to -1.52	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group	—	-1.16 Log10 Copies/mL Interval -1.56 to -0.77	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group	—	-1.32 Log10 Copies/mL Interval -1.72 to -0.91	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group	—	-1.36 Log10 Copies/mL Interval -1.83 to -0.89	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL Day 1	0.0 Percentage of participants Interval 0.0 to 23.2	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL Day 8	14.3 Percentage of participants Interval 1.8 to 42.8	0.0 Percentage of participants Interval 0.0 to 41.0	14.3 Percentage of participants Interval 0.4 to 57.9	0.0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL Day 1	0.0 Percentage of participants Interval 0.0 to 23.2	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL Day 8	14.3 Percentage of participants Interval 1.8 to 42.8	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Day 1 (baseline) and Day 8

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.

Outcome measures

Outcome measures
Measure	DOR + ART n=14 Participants HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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 + ART n=7 Participants HTE participants with HIV-1 infection took 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.
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL Day 1	0.0 Percentage of participants Interval 0.0 to 23.2	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0
Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL Day 8	14.3 Percentage of participants Interval 1.8 to 42.8	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0	0.0 Percentage of participants Interval 0.0 to 41.0

SECONDARY outcome

Timeframe: Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25	—	64.7 Percentage of participants Interval 46.5 to 80.3	—	—

SECONDARY outcome

Timeframe: Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49	—	77.4 Percentage of participants Interval 58.9 to 90.4	—	—

SECONDARY outcome

Timeframe: Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97	—	80.8 Percentage of participants Interval 60.6 to 93.4	—	—

SECONDARY outcome

Timeframe: Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25	—	58.8 Percentage of participants Interval 40.7 to 75.4	—	—

SECONDARY outcome

Timeframe: Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49	—	71.0 Percentage of participants Interval 52.0 to 85.8	—	—

SECONDARY outcome

Timeframe: Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97	—	69.2 Percentage of participants Interval 48.2 to 85.7	—	—

SECONDARY outcome

Timeframe: Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=34 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25	—	58.8 Percentage of participants Interval 40.7 to 75.4	—	—

SECONDARY outcome

Timeframe: Week 49

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.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=31 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49	—	71.0 Percentage of participants Interval 52.0 to 85.8	—	—

SECONDARY outcome

Timeframe: Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=26 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97	—	69.2 Percentage of participants Interval 48.2 to 85.7	—	—

SECONDARY outcome

Timeframe: Week 25

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

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.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=12 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25	—	33.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 49

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

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.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49	—	28.6 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 25

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

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.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=12 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25	—	8.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 49

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49	—	14.3 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 25

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

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.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=12 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25	—	25.0 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 49

Population: Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance.

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49	—	28.6 Percentage of participants	—	—

SECONDARY outcome

Timeframe: Week 25

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=12 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS A98G	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS D67N	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS H221Y	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS K103S	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS K219E	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS L234I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS M184V	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS M41L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS N348I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS V106A	—	3 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS V106I	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS V106M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS V179I	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS Y318F	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS F53L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS L90M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 RAS M36I	—	1 Participants	—	—

SECONDARY outcome

Timeframe: Week 49

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=7 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS A98G	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS D67N	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS K103S	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS K219E	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS M184V	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS M41L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS N348I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS V106A	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS V106I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS V106M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS V179I	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS F53L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS L90M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 RAS M36I	—	1 Participants	—	—

SECONDARY outcome

Timeframe: Week 97

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=5 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS D67N	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS M41L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS N348I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS T215F	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS V106A	—	2 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS V106I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS V106M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS V179I	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS F53L	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS L90M	—	1 Participants	—	—
Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 RAS M36I	—	1 Participants	—	—

SECONDARY outcome

Timeframe: Week 25

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=35 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25	—	12 Participants	—	—

SECONDARY outcome

Timeframe: Week 49

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=35 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49	—	7 Participants	—	—

SECONDARY outcome

Timeframe: Week 97

Population: All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load.

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=35 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97	—	5 Participants	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=30 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group	—	50.3 cells/mm^3 Interval 27.8 to 72.9	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=30 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group	—	86.9 cells/mm^3 Interval 51.2 to 122.5	—	—

SECONDARY outcome

Timeframe: Day 1 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=24 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group	—	114.6 cells/mm^3 Interval 54.7 to 174.6	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 25

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=30 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group	—	38.0 cells/mm^3 Interval 9.6 to 66.4	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 49

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=30 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group	—	75.1 cells/mm^3 Interval 36.9 to 113.4	—	—

SECONDARY outcome

Timeframe: Day 8 (baseline) and Week 97

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,

Outcome measures

Outcome measures
Measure	DOR + ART HTE participants with HIV-1 infection took 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.	ISL + ART n=24 Participants HTE participants with HIV-1 infection took 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.	DOR/ISL + ART HTE participants with HIV-1 infection took 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 + ART HTE participants with HIV-1 infection took 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.
Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group	—	108.0 cells/mm^3 Interval 47.9 to 168.2	—	—

Adverse Events

ISL+ART

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

DOR+ART

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

DOR/ISL+ART

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo+ART

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ISL+ART n=7 participants at risk HTE participants with HIV-1 infection took islatravir (ISL) 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg doravirine (DOR)/0.75 mg ISL fixed dose combination (FDC) QD + optimized background therapy (OBT) from Day 8 to Week 97.	DOR+ART n=14 participants at risk HTE participants with HIV-1 infection took 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.	DOR/ISL+ART n=7 participants at risk HTE participants with HIV-1 infection took 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+ART n=7 participants at risk HTE participants with HIV-1 infection took 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.
Cardiac disorders Angina pectoris	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Infections and infestations COVID-19	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	7.1% 1/14 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Infections and infestations COVID-19 pneumonia	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Infections and infestations Postoperative wound infection	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	7.1% 1/14 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Infections and infestations SARS-CoV-2 sepsis	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Injury, poisoning and procedural complications Lower limb fracture	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Injury, poisoning and procedural complications Reactive gastropathy	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/14 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	14.3% 1/7 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Castleman's disease	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	7.1% 1/14 • Number of events 1 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.	0.00% 0/7 • All-Cause Mortality (ACM): from randomization up to Week 49; Adverse Events (AE): from treatment ( Day 1) Up to Week 97 All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER