Trial Outcomes & Findings for 'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor (NCT NCT04019873)

NCT ID: NCT04019873

Last Updated: 2025-01-22

Results Overview

Recruitment status

COMPLETED

Target enrollment

774 participants

Primary outcome timeframe

At Week 24

Results posted on

2025-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment-naïve Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Overall Study STARTED	23	735	16
Overall Study COMPLETED	22	696	14
Overall Study NOT COMPLETED	1	39	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment-naïve Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Overall Study Discontinued from the treatment	1	39	2

Baseline Characteristics

'COMBINE-2': Real-world Evidence for Effectiveness of Two Drug Regimen, Antiretroviral Therapy With Integrase Inhibitors Plus a Reverse Transcriptase Inhibitor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.	Total n=774 Participants Total of all reporting groups
Age, Customized	37 Years n=5 Participants	54 Years n=7 Participants	57 Years n=5 Participants	53 Years n=4 Participants
Sex/Gender, Customized Male	19 Participants n=5 Participants	556 Participants n=7 Participants	13 Participants n=5 Participants	588 Participants n=4 Participants
Sex/Gender, Customized Female	3 Participants n=5 Participants	176 Participants n=7 Participants	3 Participants n=5 Participants	182 Participants n=4 Participants
Sex/Gender, Customized Transgender	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Sex/Gender, Customized Other, Unspecified	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	16 Participants n=5 Participants	492 Participants n=7 Participants	12 Participants n=5 Participants	520 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	140 Participants n=7 Participants	3 Participants n=5 Participants	144 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	9 Participants n=4 Participants
Race/Ethnicity, Customized Other, unspecified	6 Participants n=5 Participants	95 Participants n=7 Participants	0 Participants n=5 Participants	101 Participants n=4 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=20 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants With Human Immunodeficiency Virus Ribonucleic Acid (HIV-RNA) Levels Less Than (<)50 Copies/Milliliter (c/mL) at 24 Weeks After 2DR (Two-drug Regimen) Initiation	19 Participants	—	—

PRIMARY outcome

Timeframe: At Week 48

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 48-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=19 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 48 Weeks After 2DR Initiation	19 Participants	—	—

PRIMARY outcome

Timeframe: At Week 96

Population: Analysis population included only the Treatment-naïve participants who had a viral load (VL) measurement at the specified time point (at the 96-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=20 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants With HIV-RNA Levels <50 c/mL at 96 Weeks After 2DR Initiation	20 Participants	—	—

PRIMARY outcome

Timeframe: At Week 24

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 24-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 24	14 Participants	—	—

PRIMARY outcome

Timeframe: At Week 48

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 48-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=12 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 48	11 Participants	—	—

PRIMARY outcome

Timeframe: At Week 96

Population: Analysis population included only the Prior virological failure participants who had a viral load (VL) measurement at the specified time point (at the 96-week time point). Stable switch participants were not included in the analysis, as these participants were already suppressed (HIV RNA \<50 c/mL) at baseline. Per the protocol, the primary endpoints of suppression at 24, 48, and 96 weeks were only evaluated for Treatment-naïve participants and Prior virological failure participants.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=12 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants With HIV-RNA Levels <50 c/mL at Week 96	10 Participants	—	—

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Analysis population included all the individuals, (among the Treatment-naïve participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment for HIV infection, and who had at least one VL measurement up to the specified time point.

VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA level greater than or equal to \[\>=\] 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL\>=200 copies/mL after at least 24 weeks of treatment).

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants Experiencing Virologic Failure (VF) [Up to 24 Weeks]	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to 48 weeks

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants Experiencing VF [Up to 48 Weeks]	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to 96 weeks

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-naïve Participants Experiencing VF [Up to 96 Weeks]	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to Week 24

Population: Analysis population included all the individuals, (among the Stable switch participants) who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period (as a switching treatment option for HIV infection, whilst virologically suppressed on current treatment) and who had a VL measurement up to the specified time point.

VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Stable Switch Participants With VF Within the First 24 Weeks	1 Participants	—	—

PRIMARY outcome

Timeframe: Up to Week 48

VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Stable Switch Participants With VF Within the First 48 Weeks	3 Participants	—	—

PRIMARY outcome

Timeframe: Up to Week 96

VF was defined as 2 consecutive HIV RNA \>=50 c/mL or 1 HIV RNA \>50c/mL followed by study treatment discontinuation or missing value.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Stable Switch Participants With VF Within the First 96 Weeks	10 Participants	—	—

PRIMARY outcome

Timeframe: Up to 24 weeks

Population: Analysis population included all the individuals, among the Prior virological failure participants, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a second-line treatment, due to VF on prior treatment, and who had a VL measurement up to the specified time point.

VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 24 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 24 Weeks]	0 Participants	—	—

PRIMARY outcome

Timeframe: Up to 48 weeks

VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 48 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 48 Weeks]	1 Participants	—	—

PRIMARY outcome

Timeframe: Up to 96 weeks

VF was defined as virologic rebound (after achieving suppression, 2 consecutive HIV RNA \>= 50 copies/mL or 1 HIV RNA level \>=50 copies/mL followed by study treatment discontinuation) or virologic non-response (2 consecutive VL \>=200 copies/mL after at least 96 weeks of treatment). Treatment-experienced viremic participants refers to individuals who have previously undergone HIV treatment but had virological failure in prior treatment.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Treatment-experienced Viremic Participants Experiencing VF [Up to 96 Weeks]	3 Participants	—	—

SECONDARY outcome

Timeframe: At Week 24, Week 48 and Week 96

Population: Analysis population included (only) the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had a VL measurement at the specified time points.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=20 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks At 24 weeks	0 Participants	1 Participants	2 Participants
Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks At 48 weeks	0 Participants	1 Participants	1 Participants
Number of Participants With HIV RNA Levels >=200 c/mL After 24 Weeks, 48 Weeks and 96 Weeks At 96 weeks	0 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: At Week 24, Week 48 and Week 96

Low level viremia was defined as virologic load \>=50 and \<200 c/mL.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=20 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants With Low Level Viremia At 24 weeks	1 Participants	6 Participants	0 Participants
Number of Participants With Low Level Viremia At 48 weeks	0 Participants	8 Participants	0 Participants
Number of Participants With Low Level Viremia At 96 weeks	0 Participants	5 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: Number of participants analyzed (N=23, 15) signifies participants who were evaluable for this outcome measure. As pre-specified in the protocol, a total of at least 90 treatment-naïve participants and 90 prior virologic failure participants should have been included for the power calculation of this endpoint.

Suppression of VL was evaluated at 24 weeks, 48 weeks and 96 weeks and time to virologic suppression was planned to be evaluated until 96 weeks.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=15 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Time to Virologic Suppression Among Treatment-naïve Participants and Treatment-experienced Viremic Participants, Who Achieved Suppression	NA Months NA signifies that median, lower and upper limit could not be estimated due to insufficient number of participants with events for fulfilling the power calculations. Data was used only for the descriptive purposes.	NA Months NA signifies that median, lower and upper limit could not be estimated due to insufficient number of participants with events for fulfilling the power calculations. Data was used only for the descriptive purposes.	—

SECONDARY outcome

Timeframe: Up to Week 96

Population: Number of participants analyzed (N=10) signifies participants who were evaluable for this outcome measure. As pre-specified in the protocol, a total of at least 320 stable switch participants should have been included for the power calculation of this endpoint.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=10 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Time to Virologic Failure in the Stable Switch Population	NA Months NA signifies that median, lower and upper limit could not be estimated due to insufficient number of participants with events for fulfilling the power calculations. Data was used only for the descriptive purposes.	—	—

SECONDARY outcome

Timeframe: Up to Week 96

Population: Analysis population included (only) the individuals,who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment,or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had a VL measurement at the specified time points. No participants had emergent resistance mutations following VF events

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants With Emergent Resistance Mutations Following Virologic Failure (VF) Events	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment, and who had at least one VL measurement up to the specified time point.

A stable switch was defined as a switching option for participants with HIV RNA suppression on current treatment with viral load \<50 c/mL at time of switch.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants Who Discontinue Their Baseline 2DR and Who Stable Switch to a Different Regimen While Virologically Suppressed (HIV RNA <50 Copies/mL) at Switch	1 Participants	35 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Virologic rebound or virologic non-response in participants, was considered as virologic failure.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants Who Discontinue Their Baseline 2DR and Who Switch Following Virologic Failure	0 Participants	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 96

Population: Analysis population included all the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment and had safety data collected in terms of drug related adverse events (AEs) and serious adverse events (SAEs) since first starting 2DR treatment.

Safety reasons include tolerability, toxicity and other reasons.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants Who Discontinue Their Baseline 2DR Who Are Switching for Safety or Other Reasons	1 Participants	33 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 96

An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any untoward event resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Determination of an event as AE or SAE was at the discretion of the treating clinician and taken from the medical record.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=23 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=735 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Number of Participants With AEs and SAEs AEs	1 Participants	39 Participants	1 Participants
Number of Participants With AEs and SAEs SAEs	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline (Week 0), Week 24, Week 48 and Week 96

Population: Analysis population included only the individuals, who had initiated a 2DR with an integrase inhibitor plus a reverse transcriptase inhibitor prior to or during the study period, as a first-line treatment, or as a switching treatment option whilst virologically suppressed on current treatment, or as a second-line treatment, due to VF on prior treatment and who had immunological data collected since first starting 2DR treatment.

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=17 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=509 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=13 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD4 Count, Week 0	411 cells per cubic millimeter (cells/mm^3) Interval 340.0 to 553.0	684 cells per cubic millimeter (cells/mm^3) Interval 534.0 to 920.0	674 cells per cubic millimeter (cells/mm^3) Interval 523.0 to 807.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD4 Count, Week 24	579 cells per cubic millimeter (cells/mm^3) Interval 477.0 to 693.0	712 cells per cubic millimeter (cells/mm^3) Interval 534.0 to 956.0	709 cells per cubic millimeter (cells/mm^3) Interval 541.0 to 980.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD4 Count, Week 48	634 cells per cubic millimeter (cells/mm^3) Interval 465.0 to 976.0	709 cells per cubic millimeter (cells/mm^3) Interval 520.0 to 921.0	801 cells per cubic millimeter (cells/mm^3) Interval 576.0 to 883.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD4 Count, Week 96	741 cells per cubic millimeter (cells/mm^3) Interval 610.0 to 1033.0	694 cells per cubic millimeter (cells/mm^3) Interval 528.0 to 898.0	804 cells per cubic millimeter (cells/mm^3) Interval 505.0 to 1151.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD8 Count, Week 0	875 cells per cubic millimeter (cells/mm^3) Interval 677.0 to 1914.0	798 cells per cubic millimeter (cells/mm^3) Interval 585.0 to 1046.0	1015 cells per cubic millimeter (cells/mm^3) Interval 744.0 to 1179.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD8 Count, Week 24	709 cells per cubic millimeter (cells/mm^3) Interval 564.0 to 812.0	796 cells per cubic millimeter (cells/mm^3) Interval 587.0 to 1118.0	879 cells per cubic millimeter (cells/mm^3) Interval 645.0 to 1396.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD8 Count, Week 48	688 cells per cubic millimeter (cells/mm^3) Interval 661.0 to 1804.0	794 cells per cubic millimeter (cells/mm^3) Interval 586.0 to 1027.0	879 cells per cubic millimeter (cells/mm^3) Interval 640.0 to 1171.0
Cluster of Differentiation (CD)4+ and CD8+ T Cell Counts CD8 Count, Week 96	1548 cells per cubic millimeter (cells/mm^3) Interval 930.0 to 2162.0	786 cells per cubic millimeter (cells/mm^3) Interval 558.0 to 1033.0	932 cells per cubic millimeter (cells/mm^3) Interval 760.0 to 1260.0

SECONDARY outcome

Timeframe: At baseline (Week 0), Week 24, Week 48 and Week 96

Outcome measures

Outcome measures
Measure	Treatment-naïve Participants n=10 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for HIV infection.	Stable Switch Participants n=486 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=13 Participants Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
CD4/CD8 Ratio CD4/CD8, Week 48	1.02 Ratio Interval 0.7 to 1.38	0.89 Ratio Interval 0.64 to 1.24	0.90 Ratio Interval 0.39 to 1.5
CD4/CD8 Ratio CD4/CD8, Week 96	0.79 Ratio Interval 0.54 to 1.06	0.95 Ratio Interval 0.65 to 1.29	0.95 Ratio Interval 0.52 to 1.52
CD4/CD8 Ratio CD4/CD8, Week 0	0.60 Ratio Interval 0.41 to 0.88	0.88 Ratio Interval 0.61 to 1.24	0.72 Ratio Interval 0.36 to 0.9
CD4/CD8 Ratio CD4/CD8, Week 24	0.72 Ratio Interval 0.66 to 1.06	0.89 Ratio Interval 0.66 to 1.28	0.75 Ratio Interval 0.43 to 1.31

Adverse Events

Treatment-naïve Participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Stable Switch Participants

Serious events: 2 serious events

Other events: 39 other events

Deaths: 0 deaths

Prior Virological Failure Participants

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment-naïve Participants n=23 participants at risk Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a first-line treatment for Human Immunodeficiency Virus (HIV) infection.	Stable Switch Participants n=735 participants at risk Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a switching treatment option for HIV infection, whilst virologically suppressed (whilst having HIV RNA suppression) on current treatment.	Prior Virological Failure Participants n=16 participants at risk Participants received a two-drug regimen (2DR) consisting of an integrase inhibitor plus a reverse transcriptase inhibitor, as a second-line treatment for HIV infection, due to virological failure (VF) on prior treatment.
General disorders Low mood	0.00% 0/23 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.14% 1/735 • Number of events 1 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/16 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.
General disorders Anxiety and depression	0.00% 0/23 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.14% 1/735 • Number of events 1 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/16 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.
General disorders Memory impairment	4.3% 1/23 • Number of events 1 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/735 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/16 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.
General disorders Insomnia	4.3% 1/23 • Number of events 1 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/735 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/16 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.
General disorders Nodding head syndrome	4.3% 1/23 • Number of events 1 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/735 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.	0.00% 0/16 • Non-serious AEs and serious AEs were collected from the day of the first exposure to the 2DR (date when 2DR was prescribed) until week 96, or at the earliest of the following events: date of last study contact, date of 2DR treatment discontinuation (except if the participant was switched to another 2DR), or the date of lost to follow-up. Serious and non-serious AEs reported in this module are presented under general disorders organ system classification as they were not classified initially by the physician during adverse events collection through the study.

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER