Trial Outcomes & Findings for Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (NCT NCT04636437)

Results Overview

The percentage change is defined as weight at week 48 minus weight at entry, then divided by weight at entry, then multiplied by 100. Mean and confidence interval (CI) come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

147 participants

Primary outcome timeframe

Entry to week 48

Results posted on

2025-07-02

Participant Flow

Participants were enrolled from July 27, 2021 to November 30, 2023 at 27 sites in the US.

Participant milestones

Participant milestones
Measure	DOR 100 mg + TAF/FTC By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Overall Study STARTED	49	49	49
Overall Study COMPLETED	39	45	43
Overall Study NOT COMPLETED	10	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	DOR 100 mg + TAF/FTC By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Overall Study Eligibility failure discovered after study entry	2	1	0
Overall Study Started weight loss drug/program	2	1	1
Overall Study Lost to Follow-up	3	1	4
Overall Study Participant or physician decision	3	1	1

Baseline Characteristics

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DOR 100 mg + TAF/FTC n=47 Participants By mouth daily with or without food. Participants will receive a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) will be acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=49 Participants By mouth daily with or without food. Participants will receive a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) will be acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=49 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) will be acquired through the standard of care locally.	Total n=145 Participants Total of all reporting groups
Age, Continuous	48 years n=5 Participants	50 years n=7 Participants	52 years n=5 Participants	49 years n=4 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	24 Participants n=5 Participants	71 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	25 Participants n=5 Participants	74 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	38 Participants n=7 Participants	43 Participants n=5 Participants	117 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	26 Participants n=7 Participants	27 Participants n=5 Participants	77 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	19 Participants n=5 Participants	62 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Region of Enrollment United States	47 participants n=5 Participants	49 participants n=7 Participants	49 participants n=5 Participants	145 participants n=4 Participants
Weight	107.3 kg n=5 Participants	95.9 kg n=7 Participants	101.3 kg n=5 Participants	99.7 kg n=4 Participants
BMI	36.9 kg/m^2 n=5 Participants	34.4 kg/m^2 n=7 Participants	34.9 kg/m^2 n=5 Participants	34.9 kg/m^2 n=4 Participants

PRIMARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The percentage change is defined as weight at week 48 minus weight at entry, then divided by weight at entry, then multiplied by 100. Mean and confidence interval (CI) come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=39 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Body Weight (kg) From Entry to Week 48	-0.47 relative change % Interval -2.09 to 1.14	-2.73 relative change % Interval -4.22 to -1.23	-1.84 relative change % Interval -3.37 to -0.3

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The percentage change is defined as weight at week 24 minus weight at entry, then divided by weight at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry weight, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=44 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=45 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Body Weight (kg) From Entry to Week 24	0.44 relative change % Interval -0.69 to 1.56	-2.37 relative change % Interval -3.46 to -1.29	-0.39 relative change % Interval -1.5 to 0.72

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as waist circumference at week 48 minus waist circumference at entry. Mean and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=39 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Waist Circumference From Entry to Week 48	1.70 cm Interval -0.22 to 3.62	-1.51 cm Interval -3.3 to 0.28	-0.02 cm Interval -1.85 to 1.82

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as waist circumference at week 24 minus waist circumference at entry. Mean and CI come from a linear regression model adjusting for entry waist circumference, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=45 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Waist Circumference From Entry to Week 24	1.03 cm Interval -0.88 to 2.94	-0.29 cm Interval -2.11 to 1.54	1.19 cm Interval -0.68 to 3.06

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as triglycerides at week 48 minus triglycerides at entry. Mean and CI come from a linear regression model adjusting for entry triglycerides, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=37 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Triglycerides From Entry to Week 48	1.23 mg/dL Interval -13.7 to 16.19	-7.07 mg/dL Interval -21.0 to 6.86	0.03 mg/dL Interval -13.9 to 13.93

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as triglycerides at week 24minus triglycerides at entry. Mean and CI come from a linear regression model adjusting for entry triglycerides, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=44 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Triglycerides From Entry to Week 24	2.21 mg/dL Interval -18.3 to 22.69	-1.10 mg/dL Interval -21.4 to 19.17	17.42 mg/dL Interval -3.31 to 38.16

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as LDL at week 48 minus LDL at entry. Mean and CI come from a linear regression model adjusting for entry LDL, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=37 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=42 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Low-density Lipoprotein (LDL) Cholesterol From Entry to Week 48	-4.89 mg/dL Interval -12.2 to 2.4	-8.92 mg/dL Interval -15.7 to -2.18	-2.04 mg/dL Interval -8.93 to 4.84

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as LDL at week 24 minus LDL at entry. Mean and CI come from a linear regression model adjusting for entry LDL, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=44 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=42 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Low-density Lipoprotein (LDL) Cholesterol From Entry to Week 24	0.24 mg/dL Interval -5.31 to 5.79	-11.9 mg/dL Interval -17.4 to -6.4	3.16 mg/dL Interval -2.57 to 8.89

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as HDL at week 48 minus HDL at entry. Mean and CI come from a linear regression model adjusting for entry HDL, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=37 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting High-density Lipoprotein (HDL) Cholesterol From Entry to Week 48	3.56 mg/dL Interval -0.86 to 7.98	-2.71 mg/dL Interval -6.77 to 1.36	2.75 mg/dL Interval -1.34 to 6.85

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as HDL at week 24 minus HDL at entry. Mean and CI come from a linear regression model adjusting for entry HDL, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=44 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting High-density Lipoprotein (HDL) Cholesterol From Entry to Week 24	-0.23 mg/dL Interval -1.96 to 1.49	-4.31 mg/dL Interval -6.0 to -2.61	1.15 mg/dL Interval -0.6 to 2.9

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as glucose at week 48 minus glucose at entry. Mean and CI come from a linear regression model adjusting for entry glucose, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=37 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=42 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Glucose From Entry to Week 48	5.43 mg/dL Interval -2.12 to 12.98	-1.35 mg/dL Interval -8.37 to 5.66	3.88 mg/dL Interval -3.22 to 10.97

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

The absolute change is defined as glucose at week 24 minus glucose at entry. Mean and CI come from a linear regression model adjusting for entry glucose, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=43 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=45 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Glucose From Entry to Week 24	2.31 mg/dL Interval -3.21 to 7.84	-4.19 mg/dL Interval -9.6 to 1.12	2.13 mg/dL Interval -3.4 to 7.66

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population without insulin use and with data available at all timepoints. The eligible treated population without insulin use includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria and were not taking insulin.

The absolute change is defined as insulin at week 48 minus insulin at entry. Mean and CI come from a linear regression model adjusting for entry insulin, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=32 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=40 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=41 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Insulin From Entry to Week 48	5.20 μU/ml Interval -3.29 to 13.7	6.02 μU/ml Interval -1.57 to 13.62	-2.86 μU/ml Interval -10.4 to 4.66

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population without insulin use and with data available at all timepoints. The eligible treated population without insulin use includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria and were not taking insulin.

The absolute change is defined as insulin at week 24 minus insulin at entry. Mean and CI come from a linear regression model adjusting for entry insulin, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=37 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=43 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Fasting Insulin From Entry to Week 24	5.86 μU/ml Interval -0.96 to 12.68	1.95 μU/ml Interval -4.47 to 8.37	1.57 μU/ml Interval -4.78 to 7.93

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population without insulin use and with data available at all timepoints. The eligible treated population without insulin use includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria and were not taking insulin.

The absolute change is defined as HOMA-IR at week 48 minus HOMA-IR at entry. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a method used to estimate how well the body responds to insulin and is calculated with the following formula: (Fasting insulin, μU/ml)\*(Fasting glucose, mg/dL) / 405 Mean and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=32 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=38 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=40 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Insulin Resistance (HOMA-IR) From Entry to Week 48	1.77 μU/ml Interval -1.38 to 4.93	1.21 μU/ml Interval -1.69 to 4.11	-1.00 μU/ml Interval -3.83 to 1.83

SECONDARY outcome

Timeframe: Entry to week 24

Population: Analysis was done in the eligible treated population without insulin use and with data available at all timepoints. The eligible treated population without insulin use includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria and were not taking insulin.

The absolute change is defined as HOMA-IR at week 24 minus HOMA-IR at entry. HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) is a method used to estimate how well the body responds to insulin and is calculated with the following formula: (Fasting insulin, μU/ml)\*(Fasting glucose, mg/dL) / 405 Mean and CI come from a linear regression model adjusting for entry HOMA-IR, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=41 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=41 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Absolute) in Insulin Resistance (HOMA-IR) From Entry to Week 24	1.87 μU/ml Interval -0.35 to 4.08	-0.49 μU/ml Interval -2.55 to 1.57	0.08 μU/ml Interval -1.97 to 2.13

SECONDARY outcome

Timeframe: Entry through week 48

Population: Analysis was done in the treated population. This includes all participants who received at least one dose of their randomized study treatment.

Number of participants with confirmed plasma HIV-1 RNA \>200 copies/mL, defined as two consecutive results above 200 copies, with the drawing of the second specimen within 2 weeks of site receipt of the first result, and the first result being from a specimen drawn after treatment initiation.

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=49 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=49 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Number of Participants With Confirmed Plasma HIV-1 RNA >200 Copies/mL	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the treated population. This includes all participants who received at least one dose of their randomized study treatment.

Proportion of participants with Grade ≥3 AEs Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017. Adverse events are graded on a scale from 1-5: 1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death.

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=49 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=49 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Proportion of Participants With Grade ≥3 AEs From Entry to Week 48	0.23 proportion of participants Interval 0.12 to 0.38	0.20 proportion of participants Interval 0.1 to 0.34	0.31 proportion of participants Interval 0.18 to 0.45

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the treated population. This includes all participants who received at least one dose of their randomized study treatment.

CrCl was estimated by the 2021 CKD-EPI equation and was measured at entry, week 4, week 12, week 24, and week 48. The percentage change is defined as CrCl at an on study visit minus CrCl at entry, then divided by CrCl at entry, then multiplied by 100. Participants were categorized as experiencing a \>10% reduction in CrCl if they experienced the \>10% reduction at any of the study visits (week 4, week 12, week 24, and week 48).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=49 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=49 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Proportion of Participants With >10% Reduction in Creatinine Clearance (CrCl) From Entry to Week 48	0.23 proportion of participants Interval 0.12 to 0.38	0.31 proportion of participants Interval 0.18 to 0.45	0.49 proportion of participants Interval 0.34 to 0.64

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the treated population. This includes all participants who received at least one dose of their randomized study treatment.

Proportion of participants who permanently discontinued any component of study treatment prior to completion of a week 48 visit following randomization

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=47 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=49 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=49 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Proportion of Participants With Premature Discontinuation of Study Treatment	0.19 proportion of participants Interval 0.09 to 0.33	0.14 proportion of participants Interval 0.06 to 0.27	0.10 proportion of participants Interval 0.03 to 0.22

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Total fat was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as total fat at week 48 minus total fat at entry, then divided by total fat at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=40 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Total Fat (kg) From Entry to Week 48	0.60 relative change % Interval -2.62 to 3.82	-2.92 relative change % Interval -5.86 to 0.03	-2.83 relative change % Interval -5.83 to 0.16

SECONDARY outcome

Timeframe: Day 0 to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Lean mass was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as lean mass at week 48 minus lean mass at entry, then divided by lean mass at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry lean mass, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=40 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Lean Mass (kg) From Entry to Week 48	-1.79 relative change % Interval -3.38 to -0.2	-0.86 relative change % Interval -2.29 to 0.58	-2.10 relative change % Interval -3.57 to -0.63

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Trunk fat was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as trunk fat at week 48 minus trunk fat at entry, then divided by trunk fat at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry trunk fat, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=40 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Trunk Fat (kg) From Entry to Week 48	1.32 relative change % Interval -2.63 to 5.26	-3.75 relative change % Interval -7.34 to -0.15	-2.39 relative change % Interval -6.07 to 1.28

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Limb fat was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as limb fat at week 48 minus limb fat at entry, then divided by limb fat at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry total fat, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=34 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=39 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Limb Fat (kg) From Entry to Week 48	0.78 relative change % Interval -2.83 to 4.38	-1.65 relative change % Interval -4.92 to 1.61	-3.41 relative change % Interval -6.76 to -0.07

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Appendicular lean mass was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as appendicular lean mass at week 48 minus appendicular lean mass at entry, then divided by appendicular lean mass at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry appendicular lean mass, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=34 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=39 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Appendicular Lean Mass (kg) From Entry to Week 48	-0.23 relative change % Interval -3.02 to 2.56	0.73 relative change % Interval -1.75 to 3.21	-2.42 relative change % Interval -5.0 to 0.17

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Hip bone mineral density was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as hip bone mineral density at week 48 minus hip bone mineral density at entry, then divided by hip bone mineral density at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry hip bone mineral density, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=40 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=39 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Hip Bone Mineral Density (g/cm2) From Entry to Week 48	0.60 relative change % Interval -0.25 to 1.46	-0.81 relative change % Interval -1.61 to -0.01	-0.17 relative change % Interval -0.98 to 0.63

SECONDARY outcome

Timeframe: Entry to week 48

Population: Analysis was done in the eligible treated population with data available at all timepoints. The eligible treated population includes all participants who received at least one dose of randomized study treatment and who were eligible as per eligibility criteria.

Lumbar spine bone mineral density was measured by DEXA (dual-energy x-ray absorptiometry) scan. The percentage change is defined as lumbar spine bone mineral density at week 48 minus lumbar spine bone mineral density at entry, then divided by lumbar spine bone mineral density at entry, then multiplied by 100. Mean and CI come from a linear regression model adjusting for entry lumbar spine bone mineral density, sex, and race (Black and not Black).

Outcome measures

Outcome measures
Measure	DOR 100 mg + TAF/FTC n=35 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through the standard of care locally.	DOR 100 mg + TDF/FTC n=42 Participants By mouth daily with or without food. Participants received a Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through the standard of care locally.	Continuation of INSTI+TAF/FTC n=40 Participants By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through the standard of care locally.
Mean Change (Percent) in Lumbar Spine Bone Mineral Density (g/cm2) From Entry to Week 48	0.88 relative change % Interval -0.44 to 2.2	0.43 relative change % Interval -0.78 to 1.64	0.38 relative change % Interval -0.86 to 1.61

Adverse Events

DOR 100 mg + TAF/FTC

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

DOR 100 mg + TDF/FTC

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Continuation of Entry INSTI+TAF/FTC

Serious events: 3 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DOR 100 mg + TAF/FTC n=47 participants at risk By mouth daily with or without food. Participants received Doravirine 100 mg tablet by mouth daily. NRTIs (TAF/FTC) were acquired through standard of care locally.	DOR 100 mg + TDF/FTC n=49 participants at risk By mouth daily with or without food. Participants received Doravirine 100 mg tablet by mouth daily. NRTIs (TDF/FTC) were acquired through standard of care locally.	Continuation of Entry INSTI+TAF/FTC n=49 participants at risk By mouth daily with or without food. INSTIs and NRTIs (TAF/FTC) were acquired through standard of care locally.
General disorders Systemic inflammatory response syndrome	0.00% 0/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	2.0% 1/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Hepatobiliary disorders Cholelithiasis	0.00% 0/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	2.0% 1/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Infections and infestations Bacterial sepsis	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Infections and infestations Herpes zoster disseminated	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Infections and infestations Sepsis	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Infections and infestations Urinary tract infection	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Metabolism and nutrition disorders Hypokalaemia	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	2.0% 1/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Nervous system disorders Cerebral ischaemia	0.00% 0/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	2.0% 1/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Renal and urinary disorders Acute kidney injury	0.00% 0/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	2.0% 1/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	4.1% 2/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	2.1% 1/47 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.	0.00% 0/49 • From entry to study completion at Week 48 or premature study discontinuation. All AEs were recorded on the eCRFs if any of the following criteria were met. * All Grade ≥3 AEs * All AEs that led to a change in study treatment/intervention regardless of grade * All AEs meeting serious adverse event (SAE) definition or expedited adverse event (EAE) reporting requirement The DAIDS AE Grading Table (V2.1) was used. All participants who initiated study treatment are included.

Other adverse events

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company

Phone: (301) 628-3348

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
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Restriction type: OTHER