| Primary | Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm | Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. The Full Analysis Set included all randomized participants who received at least one dose of the complete long acting study drug regimen (ie, SC LEN + TAB, ZAB) or continued with their baseline ART regimen. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 26 | | | | ID | Title | Description |
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| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | | OG001 | Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001.9(0.0 to 10.1)
- OG0010.0(0.0 to 12.8)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | 1.0000 | | Difference in Percentages | 1.9 | | | 2-Sided | 95 | -11.2 | 10.6 | | | Difference in the percentage of participants between treatments and the associated 2-sided 95% CI were constructed based on an unconditional exact method using 2 inverted 1-sided tests. | | Other | | |
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| Secondary | Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm | Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 52 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 52 analysis window and i) discontinued study drug prior to or in the Week 52 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 52 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 52 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm | Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 26 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | | OG001 | Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
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| Secondary | Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm | Percentage of participants with HIV-1 RNA < 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA < 50 copies/mL in the Week 52 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off. | Participants in the Full Analysis Set were analyzed. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | | OG001 | Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
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| Secondary | Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26 | | Participant in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Baseline, Week 26 | | | | ID | Title | Description |
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| OG000 | Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | | OG001 | Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
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| Secondary | Change From Baseline in CD4+ T-cell Counts at Week 52 | | Participant in the Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/μL | | Baseline, Week 52 | | | | ID | Title | Description |
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| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. | | OG001 | Randomized Phase Treatment Group 3: SBR | Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52. |
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| Secondary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | Trough Concentration at Week 26 Predose for TAB and ZAB | Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval. | Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed. TAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing TAB concentration value reported by the PK laboratory test. ZAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing ZAB concentration value reported by the PK laboratory test. | Posted | | Mean | Standard Deviation | µg/mL | | Week 26 predose | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB + ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. |
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| Secondary | Trough Concentration at Week 26 Predose for LEN | Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval. | Participants in the LEN PK Analysis Set with available data were analyzed. LEN PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 nonmissing LEN concentration value reported by the PK laboratory test. | Posted | | Mean | Standard Deviation | ng/mL | | Week 26 predose | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. |
| |
| Secondary | Trough Concentration at Week 52 Predose for TAB and ZAB | Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval. | Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | ug/mL | | Week 52 predose | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. |
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| Secondary | Trough Concentration at Week 52 Predose for LEN | Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval. | Participants in the LEN PK Analysis Set with available data were analyzed | Posted | | Mean | Standard Deviation | ng/mL | | Week 52 predose | | | | ID | Title | Description |
|---|
| OG000 | Randomized Phase Treatment Group 1: LEN + TAB+ ZAB | Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA < 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks. |
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| Secondary | Pharmacokinetic (PK) Parameter: AUC0-tau for TAB and ZAB | AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t". | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | PK Parameter: t1/2 for TAB and ZAB | t1/2 is defined as the terminal elimination half-life. | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | PK Parameter: Cmax for TAB and ZAB | Cmax is defined as the maximum observed concentration of drug. | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | PK Parameter: Cmax for LEN | Cmax is defined as the maximum observed concentration of drug. | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | PK Parameter: Tmax for TAB, ZAB, and LEN | Tmax is defined as the time (observed time point) of Cmax. | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |
| Secondary | Percentage of Participants With Treatment-emergent Anti-TAB and Anti-ZAB Antibodies | Anti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence. | | Not Posted | | | | | | Up to approximately 6 years | | Participants | | | | |