Trial Outcomes & Findings for Dolutegravir Plus Lamivudine Dual Therapy in Treatment Naïve HIV-1 Patients (NCT NCT02582684)

NCT ID: NCT02582684

Last Updated: 2018-05-09

Results Overview

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below. Virologic success is defined as HIV-1 RNA \<50 copies/mL and on study treatment (FDA Snapshot definition).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 122 participants
• Primary outcome timeframe: At 24 weeks after study entry
• Results posted on: 2018-05-09

Participant Flow

A total of 122 participants were accrued.

Participant milestones

Measure	Arm 1: DTG 50 MG + 3TC 300 mg Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Overall Study STARTED	122
Overall Study COMPLETED	105
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Measure	Arm 1: DTG 50 MG + 3TC 300 mg Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Overall Study Unable to contact subject/parent	4
Overall Study Subject not able to get to clinic	10
Overall Study Subject withdrew consent	1
Overall Study Found to be ineligible after enrollment	2

Baseline Characteristics

2 participants with missing baseline CD4 counts.

Baseline characteristics by cohort

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Age, Continuous Age	30 Years n=120 Participants
Age, Customized Age Category · 18-29 years	58 Participants n=120 Participants
Age, Customized Age Category · 30-39 years	29 Participants n=120 Participants
Age, Customized Age Category · 40-49 years	17 Participants n=120 Participants
Age, Customized Age Category · 50-59 years	12 Participants n=120 Participants
Age, Customized Age Category · >= 60 years	4 Participants n=120 Participants
Sex: Female, Male Female	16 Participants n=120 Participants
Sex: Female, Male Male	104 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · White Non-Hispanic	34 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black Non-Hispanic	48 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic (Regardless of Race)	32 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian, Pacific Islander	2 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · More than one race	2 Participants n=120 Participants
Race/Ethnicity, Customized Race/Ethnicity · Does not want to report	2 Participants n=120 Participants
Region of Enrollment Puerto Rico	3 Participants n=120 Participants
Region of Enrollment United States	117 Participants n=120 Participants
Intravenous Drug Use Never	113 Participants n=120 Participants
Intravenous Drug Use Currently	2 Participants n=120 Participants
Intravenous Drug Use Previously	5 Participants n=120 Participants
CD4 Count, Continuous	387 cells/mm^3 n=118 Participants • 2 participants with missing baseline CD4 counts.
CD4 Count, Categorized <200 cells/mm^3	16 Participants n=120 Participants
CD4 Count, Categorized 200-349 cells/mm^3	27 Participants n=120 Participants
CD4 Count, Categorized 350-499 cells/mm^3	30 Participants n=120 Participants
CD4 Count, Categorized 500-649 cells/mm^3	19 Participants n=120 Participants
CD4 Count, Categorized 650-799 cells/mm^3	15 Participants n=120 Participants
CD4 Count, Categorized >=800 cells/mm^3	11 Participants n=120 Participants
CD4 Count, Categorized Missing	2 Participants n=120 Participants
CD8 Count	871 cells/mm^3 n=107 Participants • Total of 13 participants missing CD8 Count at baseline.
CD4/CD8 Ratio	0.44 ratio n=107 Participants • Total of 13 participants had missing measurements that contribute to the CD4/CD8 ratio.
Screening HIV-1 RNA	4.70 log10 copies/mL n=120 Participants
Baseline HIV-1 RNA	4.61 log10 copies/mL n=120 Participants
Baseline HIV-1 RNA Category < 1,000 copies/mL	1 Participants n=120 Participants
Baseline HIV-1 RNA Category 1,000 - 9,999 copies/mL	34 Participants n=120 Participants
Baseline HIV-1 RNA Category 10,000 - 99,999 copies/mL	48 Participants n=120 Participants
Baseline HIV-1 RNA Category 100,000 - 200,000 copies/mL	23 Participants n=120 Participants
Baseline HIV-1 RNA Category > 200,000 copies/mL	14 Participants n=120 Participants
Hepatitis C Antibody Status Positive	4 Participants n=120 Participants
Hepatitis C Antibody Status Negative	116 Participants n=120 Participants
Post-exposure Prophylaxis or Pre-Exposure Prophylaxis History Yes	1 Participants n=120 Participants
Post-exposure Prophylaxis or Pre-Exposure Prophylaxis History No	119 Participants n=120 Participants

PRIMARY outcome

Timeframe: At 24 weeks after study entry

Population: All eligible participants enrolled.

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 24 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Virologic Status at Week 24 Virologic success	108 Participants
Virologic Status at Week 24 Virologic non-success	5 Participants
Virologic Status at Week 24 No virologic data in window	7 Participants

SECONDARY outcome

Timeframe: At 12 weeks after study entry

Population: All eligible participants enrolled.

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 12 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Virologic Status at Week 12 Virologic success	107 Participants
Virologic Status at Week 12 Virologic non-success	7 Participants
Virologic Status at Week 12 No virologic data in window	6 Participants

SECONDARY outcome

Timeframe: At 48 weeks after study entry

Population: All eligible participants enrolled.

Numbers of Participants With Virologic Success, Virologic Non-Success, and no Virologic Data at Week 48 Window are provided below.

Virologic success is defined as HIV-1 RNA <50 copies/mL and on study treatment (FDA Snapshot definition).

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Virologic Status at Week 48 Virologic success	102 Participants
Virologic Status at Week 48 Virologic non-success	6 Participants
Virologic Status at Week 48 No virologic data in window	12 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: All eligible participants enrolled.

Virologic failure is defined as follows:

• Weeks 16 or 20: confirmed plasma HIV-1 RNA > 400 copies/mL
• Week 24 or later: confirmed plasma HIV-1 RNA > 200 copies/mL

1. Participants were evaluated for virologic failure regardless of whether on study treatment.

2. Confirmation was determined based on any two consecutive evaluations meeting the virologic failure definition regardless of the time between them.

3. Participants discontinuing the study (for any reason, including death and lost to follow-up) were considered virologic failures if their last measurement met the definition of virologic failure but no confirmatory measurement was obtained. All other participants' follow-up was censored immediately after the last available plasma HIV-1 RNA measurement.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Virologic Failure Yes	4 Participants
Virologic Failure No	116 Participants

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA \< 50 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (Intention To Treat; missing/off study/off treatment = failure) population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 2	0.40 proportion of participants Interval 0.31 to 0.49
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 4	0.68 proportion of participants Interval 0.58 to 0.76
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 8	0.85 proportion of participants Interval 0.77 to 0.91
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 12	0.89 proportion of participants Interval 0.82 to 0.94
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 16	0.88 proportion of participants Interval 0.8 to 0.93
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 20	0.90 proportion of participants Interval 0.83 to 0.95
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 24	0.90 proportion of participants Interval 0.83 to 0.95
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 32	0.88 proportion of participants Interval 0.8 to 0.93
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 40	0.89 proportion of participants Interval 0.82 to 0.94
Proportion of Participants With Plasma HIV-1 RNA < 50 Copies/mL - Missing = Failure Week 48	0.84 proportion of participants Interval 0.76 to 0.9

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: The population here is the ITT (missing/off study/off treatment = failure) population. The numerator includes participants with HIV-1 RNA \< 200 copies/mL and still on initial treatment; the denominator includes all participants with potential for the given week of follow-up based on the date of registration.

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing/off study/off treatment = failure) population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 2	0.68 proportion of participants Interval 0.59 to 0.77
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 4	0.90 proportion of participants Interval 0.83 to 0.95
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 8	0.95 proportion of participants Interval 0.89 to 0.98
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 12	0.93 proportion of participants Interval 0.87 to 0.97
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 16	0.92 proportion of participants Interval 0.85 to 0.96
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 20	0.95 proportion of participants Interval 0.89 to 0.98
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 24	0.92 proportion of participants Interval 0.85 to 0.96
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 32	0.89 proportion of participants Interval 0.82 to 0.94
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 40	0.91 proportion of participants Interval 0.84 to 0.95
Proportion of Participants With Plasma HIV-1 RNA < 200 Copies/mL - Missing = Failure Week 48	0.87 proportion of participants Interval 0.79 to 0.92

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA \< 50 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, ITT (missing = ignored) population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 2	0.41 proportion of participants Interval 0.32 to 0.51
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 4	0.70 proportion of participants Interval 0.61 to 0.79
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 8	0.88 proportion of participants Interval 0.81 to 0.93
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 12	0.94 proportion of participants Interval 0.88 to 0.97
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 16	0.94 proportion of participants Interval 0.88 to 0.97
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 20	0.94 proportion of participants Interval 0.88 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 24	0.96 proportion of participants Interval 0.9 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 32	0.93 proportion of participants Interval 0.87 to 0.97
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 40	0.95 proportion of participants Interval 0.89 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL - Missing = Ignored Week 48	0.94 proportion of participants Interval 0.87 to 0.97

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: ITT Missing = Ignored. The numerator includes participants with HIV-1 RNA \< 200 copies/mL; the denominator includes all participants with an HIV-1 RNA evaluation at the given week.

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, ITT (missing = ignored) population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 2	0.71 proportion of participants Interval 0.62 to 0.79
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 4	0.94 proportion of participants Interval 0.88 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 8	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 12	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 16	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 20	0.99 proportion of participants Interval 0.95 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 24	0.97 proportion of participants Interval 0.93 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 32	0.95 proportion of participants Interval 0.89 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 40	0.96 proportion of participants Interval 0.91 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- ITT Missing = Ignored Week 48	0.96 proportion of participants Interval 0.91 to 0.99

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: As Treated: purely virologic missing = ignored. The numerator includes participants with HIV-1 RNA \< 50 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.

Proportion of participants with HIV-1 RNA < 50 copies/mL by week, as treated population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 2	0.41 proportion of participants Interval 0.32 to 0.51
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 4	0.70 proportion of participants Interval 0.61 to 0.79
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 8	0.88 proportion of participants Interval 0.81 to 0.93
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 12	0.94 proportion of participants Interval 0.88 to 0.97
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 16	0.94 proportion of participants Interval 0.88 to 0.97
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 20	0.94 proportion of participants Interval 0.88 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 24	0.96 proportion of participants Interval 0.91 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 32	0.95 proportion of participants Interval 0.9 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 40	0.97 proportion of participants Interval 0.92 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <50 Copies/mL- As Treated Week 48	0.97 proportion of participants Interval 0.92 to 0.99

SECONDARY outcome

Timeframe: Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40 and 48

Population: As Treated: purely virologic missing=ignored. The numerator includes participants with HIV-1 RNA \< 200 copies/mL and still on initial treatment; the denominator includes participants on initial treatment with an HIV-1 RNA evaluation at the given week.

Proportion of participants with HIV-1 RNA < 200 copies/mL by week, as treated population.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 2	0.71 proportion of participants Interval 0.62 to 0.79
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 4	0.94 proportion of participants Interval 0.88 to 0.98
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 8	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 12	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 16	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 20	0.99 proportion of participants Interval 0.95 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 24	0.98 proportion of participants Interval 0.94 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 32	0.97 proportion of participants Interval 0.92 to 0.99
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 40	0.99 proportion of participants Interval 0.95 to 1.0
Proportion of Participants With Plasma HIV-1 RNA <200 Copies/mL- As Treated Week 48	1.00 proportion of participants Interval 0.97 to 1.0

SECONDARY outcome

Timeframe: Baseline, weeks 4, 12, 24, and 48

Population: All eligible participants enrolled with CD4 count results available at a given visit.

CD4+ cell counts by study week.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
CD4+ Cell Count Week 0	387 cells/mm^3 Interval 288.0 to 596.0
CD4+ Cell Count Week 4	473 cells/mm^3 Interval 358.0 to 727.0
CD4+ Cell Count Week 12	520 cells/mm^3 Interval 395.0 to 783.0
CD4+ Cell Count Week 24	582 cells/mm^3 Interval 416.0 to 871.0
CD4+ Cell Count Week 48	579 cells/mm^3 Interval 451.0 to 830.0

SECONDARY outcome

Timeframe: Baseline, weeks 4, 12, 24, and 48

Population: All eligible participants enrolled with CD4 cell count results available at baseline and the given visit.

Change in CD4+ cell counts by study week. Change was calculated as value at the later visit minus the value at baseline.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Change in CD4+ Cell Count Change from Baseline to Week 4	78 cells/mm^3 Interval 10.0 to 154.0
Change in CD4+ Cell Count Change from Baseline to Week 12	122 cells/mm^3 Interval 67.0 to 185.0
Change in CD4+ Cell Count Change from Baseline to Week 24	167 cells/mm^3 Interval 86.0 to 275.0
Change in CD4+ Cell Count Change from Baseline to Week 48	182 cells/mm^3 Interval 104.0 to 284.0

SECONDARY outcome

Timeframe: at the time of virologic failure

Population: Of the enrolled eligible participants, those with virologic failures had resistance testing done.

Number of HIV-1 drug resistance mutation occurrences participants with virologic failure and FDA snapshot non-successes. Participants that had one drug class resistance mutation may have one or more mutations.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=4 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Number of HIV-1 Drug Resistance Mutation Occurrences in Participants NRTI mutation	1 number of mutation occurrences
Number of HIV-1 Drug Resistance Mutation Occurrences in Participants NNRTI mutation	1 number of mutation occurrences
Number of HIV-1 Drug Resistance Mutation Occurrences in Participants INI mutation	1 number of mutation occurrences

SECONDARY outcome

Timeframe: Baseline and week 48

Population: All eligible participants enrolled with lipids results available at a given time point.

Fasting lipids include: total cholesterol, triglycerides, LDL cholesterol, HDL cholesterol, and glucose. Fasting was set to be 8 hours prior to the sample collection.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Fasting Lipids and Glucose Baseline Total Cholesterol	151 mg/dL Interval 123.0 to 171.0
Fasting Lipids and Glucose Week 48 Total Cholesterol	154 mg/dL Interval 136.0 to 189.0
Fasting Lipids and Glucose Baseline LDL Cholesterol	85 mg/dL Interval 69.0 to 107.0
Fasting Lipids and Glucose Week 48 LDL Cholesterol	86 mg/dL Interval 69.0 to 117.0
Fasting Lipids and Glucose Baseline HDL Cholesterol	39 mg/dL Interval 33.0 to 49.0
Fasting Lipids and Glucose Week 48 HDL Cholesterol	46 mg/dL Interval 38.0 to 56.0
Fasting Lipids and Glucose Baseline Triglycerides	91 mg/dL Interval 70.0 to 133.0
Fasting Lipids and Glucose Week 48 Triglycerides	98 mg/dL Interval 60.0 to 150.0
Fasting Lipids and Glucose Baseline Glucose	84 mg/dL Interval 78.0 to 92.0
Fasting Lipids and Glucose Week 48 Glucose	86 mg/dL Interval 81.0 to 93.0

SECONDARY outcome

Timeframe: Baseline, weeks 4, 12, 24, 32, 40 and 48

Population: All eligible participants enrolled with creatinine clearance results available at a given time point.

Creatinine clearance was estimated by the Cockcroft-Gault equation.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Creatinine Clearance Week 0	126.0 mL/min Interval 106.8 to 139.9
Creatinine Clearance Week 4	112.9 mL/min Interval 96.6 to 133.2
Creatinine Clearance Week 12	112.0 mL/min Interval 97.8 to 133.3
Creatinine Clearance Week 24	114.7 mL/min Interval 96.8 to 132.7
Creatinine Clearance Week 32	115.5 mL/min Interval 97.1 to 138.6
Creatinine Clearance Week 40	112.7 mL/min Interval 97.4 to 138.7
Creatinine Clearance Week 48	114.4 mL/min Interval 101.2 to 133.5

SECONDARY outcome

Timeframe: from study treatment dispensation through up to week 52 or until study discontinuation

Population: All eligible participants enrolled.

Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.

Outcome measures

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=120 Participants Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Number of Participants With Grade 3 of Higher Adverse Events	16 Participants

Adverse Events

Arm 1: DTG 50 MG + 3TC 300 mg

Serious events: 3 serious events

Other events: 75 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=122 participants at risk Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Psychiatric disorders Suicidal ideation	2.5% 3/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Psychiatric disorders Suicide attempt	0.82% 1/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.

Other adverse events

Measure	Arm 1: DTG 50 MG + 3TC 300 mg n=122 participants at risk Dolutegravir: Participants were prescribed 50 mg of DTG orally daily Lamivudine: Participants were prescribed 300 mg of 3TC orally daily.
Infections and infestations Urethritis gonococcal	5.7% 7/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Alanine aminotransferase increased	6.6% 8/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Aspartate aminotransferase increased	8.2% 10/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Blood cholesterol increased	16.4% 20/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Blood creatinine abnormal	8.2% 10/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Blood glucose increased	9.0% 11/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Blood sodium decreased	5.7% 7/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Blood triglycerides increased	24.6% 30/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Low density lipoprotein increased	15.6% 19/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.
Investigations Neutrophil count decreased	9.8% 12/122 • From study entry through up to week 52 or until study discontinuation The protocol required reporting of all diagnoses (identified by the ACTG criteria for clinical events and other diseases), signs/symptoms and laboratory values of \>= Grade 3 and events that led to a change in treatment or that met ICH, EAE, or SAE guidelines, regardless of grade. Creatinine and creatinine clearance were reported regardless of grade. The DAIDS AE Grading Table (Version 2.0) and Expedited AE Manual (Version 2.0) were used.

Additional Information

ACTG Clinicaltrials.gov Coordinator

ACTG Network Coordinating Center, Social and Scientific Systems, Inc.

Phone: (301) 628-3313

Email: ACTGCT.Gov@s-3.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place