| Primary | Percentage of Participants Receiving Doravirine/Islatravir (DOR/ISL) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) Compared to Placebo Treatment | Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL FDC or placebo were analyzed in this outcome measure. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG003 | Placebo + ART | HTE participants with HIV-1 infection took placebo QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00285.7(42.1 to 99.6)
- OG0030.0(0.0 to 41.0)
|
|
| |
| Primary | Percentage of Participants With ≥1 AEs Through Week 49 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 49 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Primary | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 25 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Primary | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 25 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 25 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Primary | Percentage of Participants Withdrawing From Study Treatment Due to AE(s) Through Week 49 | An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 49 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants With ≥1 Adverse Events (AEs) Through Week 97 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 97 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants Discontinuing From Study Therapy Due to AE(s) Through Week 97 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized. | Posted | | Number | | Percentage of participants | | Up to 97 weeks | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants Receiving DOR or ISL (Given With Antiretroviral Therapy [ART]) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | Participants with a ≥0.5 log10 decrease from Day 1 baseline to Day 8 in HIV-1 RNA were identified by the central laboratory with an Abbott Real Time PCR assay which has a LLOD of 40 copies/mL Only participants treated with either DOR or ISL or placebo (given with ART) were analyzed in this outcome measure. Participants treated with DOR/ISL FDC were not analyzed in this outcome measure. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 |
|
| Secondary | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART), DOR, or ISL Compared to Placebo Treatment | The change from baseline Day to Day 8 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants Receiving DOR/ISL (Given With ART), DOR, or ISL With ≥1.0 log10 Change From Day 1 Baseline to Day 8 HIV-1 RNA Compared to Placebo Treatment | Participants with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time Polymerase Chain Reaction (PCR) assay which has a LLOD of 40 copies/mL | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | |
|
| Secondary | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥0.5 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | Participants with a ≥0.5 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 |
|
| Secondary | Mean Change From Baseline Day 1 to Day 8 in HIV-1 RNA Following Treatment With DOR/ISL (Given With ART) Compared to DOR or ISL Treatment | The change from baseline Day 1 to Day 8in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the t-distribution. The group treated with placebo were not analyzed in this outcome measure. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | |
|
| Secondary | Percentage of Participants Receiving DOR/ISL (Given With ART) With ≥1.0 log10 Change From Day 1 Baseline to Day 8 in HIV-1 RNA Compared to DOR or ISL Treatment | Participants receiving DOR/ISL with a ≥1.0 log10 decrease from baseline (Day 1) to Day 8 in HIV-1 RNA were identified by at the central laboratory with an Abbott Real Time PCR assay which has a lower limit of detection (LLOD) of 40 copies/mL Only participants treated with DOR/ISL or DOR alone or ISL alone were analyzed in this outcome measure. Participants treated with placebo were not analyzed in this outcome measure. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | |
|
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥0.5 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥0.5 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 25 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 49 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 1 Baseline to Week 97 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 25 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 49 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With ≥1.0 log10 Change From Day 8 Baseline to Week 97 in HIV-1 RNA | The percentage of participants in the pooled treatment group with ≥1.0 log10 change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 8 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 1 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 1 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 1 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 1 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 1 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 1 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 1 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 1 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 1 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 8 to Week 25 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 8 to Week 25 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 8 (baseline) and Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 8 to Week 49 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 8 to Week 49 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 8 (baseline) and Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Mean Change From Baseline Day 8 to Week 97 in HIV-1 RNA From the Pooled Treatment Group | The change from baseline Day 8 to Week 97 in HIV-1 RNA was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% confidence intervals (CIs) were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | Log10 Copies/mL | | Day 8 (baseline) and Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <200 Copies mL | The percentage of participants with HIV-1 RNA <200 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <50 Copies mL | The percentage of participants with HIV-1 RNA <50 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants From Day 1 Baseline to Day 8 With HIV-1 RNA <40 Copies mL | The percentage of participants with HIV-1 RNA <40 copies mL was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. | All randomized participants who received at least 1 dose of study intervention based on the treatment group to which they were randomized and had baseline data for those analyses that require baseline data. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Day 1 (baseline) and Day 8 | | | | ID | Title | Description |
|---|
| OG000 | ISL + ART | HTE participants with HIV-1 infection took ISL 0.75 mg once daily (QD) in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL fixed dose combination (FDC) QD + OBT from Day 8 to Week 97. | | OG001 | DOR + ART | HTE participants with HIV-1 infection took DOR 100 mg QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. | | OG002 | DOR/ISL + ART | HTE participants with HIV-1 infection took 100 mg DOR/0.75 mg ISL FDC QD in combination with failing ART from Day 1 to Day 7; followed by open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97. |
|
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 25 | The percentage of participants with HIV-1 RNA <200 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 49 | The percentage of participants with HIV-1 RNA <200 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <200 Copies/mL at Week 97 | The percentage of participants with HIV-1 RNA <200 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 25 | The percentage of participants with HIV-1 RNA <50 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 49 | The percentage of participants with HIV-1 RNA <50 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <50 Copies/mL at Week 97 | The percentage of participants with HIV-1 RNA <50 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 25 | The percentage of participants with HIV-1 RNA <40 copies mL at week 25 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 49 | The percentage of participants with HIV-1 RNA <40 copies mL at week 49 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With HIV-1 RNA <40 Copies/mL at Week 97 | The percentage of participants with HIV-1 RNA <40 copies mL at week 97 was determined by the central laboratory using an Abbott Real Time PCR assay with a LLOD of 40 copies/mL. The within-group 95% CIs were calculated based on the Clopper-Pearson method. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 97 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 25 | The prevalence of viral drug resistance to DOR was based on the percentage of participants with treatment-emergent (TE) resistance-associated substitutions (RASs), which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to DOR at Week 49 | The prevalence of viral drug resistance to DOR was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. RASs for DOR were as follows: V106A/M, Y188C/L, F227C/H/I/L, M230I/L, L234I, Y318F, V108I, Y188F/H, G190E, H221Y, P236, and were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 25 | The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to ISL at Week 49 | The prevalence of viral drug resistance to ISL was based on the percentage of participants with TE RAS, which is calculated by dividing the number of participants with TE RAS by the number of participants tested for resistance, multiplied by 100. The RAS for ISL, M184V was determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to Optimized Background Therapy (OBT) Components at Week 25 | The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Percentage of Participants From the Pooled Treatment Group With Treatment-emergent Resistance-associated Substitutions to OBT Components at Week 49 | The prevalence of viral drug resistance to OBT components was based on the percentage of participants with TE RASs, which is calculated by dividing the number of participants with TE RASs by the number of participants tested for resistance, multiplied by 100. The RASs for OBT components were determined by the central laboratory with the GenoSure Prime assay on post randomization samples from participants with HIV-1 RNA ≥200 copies/mL Analysis of the pooled treatment group was planned per protocol. | Randomized participants who received at least 1 dose of study intervention, had HIV-1 RNA ≥200 copies/mL, and were tested for resistance. | Posted | | Number | | Percentage of participants | | Week 49 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
| |
| Secondary | Number of Participants From the Pooled Treatment Group With Viral Resistance-associated Substitutions (RASs) at Week 25 | The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 25 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA 200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 25 | | | | ID | Title | Description |
|---|
| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 49 | The number of participants from the pooled treatment group who had HIV-1 RNA ≥200 copies/mL with treatment emergent RAS at week 49 showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥200 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 49 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Number of Participants From the Pooled Treatment Group With Viral RASs at Week 97 | The number of participants from the pooled treatment group with treatment emergent RAS at week 97 are presented, showing the type of RAS .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 97 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 25 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 25 is presented. .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 25 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 49 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 49 is presented. .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 49 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Number of Participants From the Pooled Treatment Group Exhibiting Antiviral Resistance of HIV-1 RNA ≥200 Copies/mL at Week 97 | The number of participants from the pooled treatment group exhibiting antiviral resistance of HIV-1 RNA ≥200 copies/mL at Week 97 is presented. .Analysis of the pooled treatment group was planned per protocol, | All randomized participants who received at least 1 dose of study intervention and had baseline data for those analyses that require baseline data. with confirmed HIV-1 RNA ≥400 copies/mL, and with available genotypic or phenotypic data that show evidence of resistance irrespective of viral load. | Posted | | Count of Participants | | Participants | | Week 97 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 1 to Week 25 in Cluster of Differentiation 4+ (CD4+) T-cell Counts From the Pooled Treatment Group | The change from baseline Day 1 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 1 (baseline) and Week 25 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 1 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | The change from baseline Day 1 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 1 (baseline) and Week 49 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 1 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | The change from baseline Day 1 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 1 (baseline) and Week 97 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 8 to Week 25 in CD4+ T-cell Counts From the Pooled Treatment Group | The change from baseline Day 8 to Week 25 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 8 (baseline) and Week 25 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 8 to Week 49 in CD4+ T-cell Counts From the Pooled Treatment Group | The change from baseline Day 8 to Week 49 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 8 (baseline) and Week 49 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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| Secondary | Change From Baseline Day 8 to Week 97 in CD4+ T-cell Counts From the Pooled Treatment Group | The change from baseline Day 8 to Week 97 in CD4+ T-cell counts was determined by the central laboratory.. The within-group 95% CIs were calculated based on the t-distribution. Analysis of the pooled treatment group was planned per protocol, | Randomized participants who received at least 1 dose of study intervention, had baseline data for those analyses that require baseline data, and had not committed any major protocol violations. Examples of protocol violations include, but are not limited to nonadherence to study intervention; or becoming pregnant. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Day 8 (baseline) and Week 97 | | | | ID | Title | Description |
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| OG000 | Pooled Treatment | HTE participants with HIV-1 infection from the original four treatment groups (DOR, ISL, DOR/ISL FDC, placebo QD) treated in combination with failing ART from Day 1 to Day 7; followed by treatment with open-label 100 mg DOR/0.75 mg ISL FDC QD + OBT from Day 8 to Week 97 were pooled into a single group as planned per protocol |
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