| Primary | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 48 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000100.0(63.1 to 100.0)
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| Primary | Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 48 | The percentage of participants experiencing ≥1 AE up to Week 48 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | All participants who received ≥1 dose of MK-1439A. | Posted | | Number | | Percentage of Participants | | Up to Week 48 | | | | ID | Title | Description |
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| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Primary | Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 48. | The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | All participants who received ≥1 dose of MK-1439A. | Posted | | Number | | Percentage of Participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Primary | Percentage of Participants Experiencing ≥1 Adverse Events (AE) up to Week 96 | The percentage of participants experiencing ≥1 AE up to Week 96 was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | All participants who received ≥1 dose of MK-1439A. | Posted | | Number | | Percentage of Participants | | Up to Week 96 | | | | ID | Title | Description |
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| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
| |
| Primary | Percentage of Participants Who Discontinued Treatment Due to an AE up to Week 96 | The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. | All participants who received ≥1 dose of MK-1439A. | Posted | | Number | | Percentage of Participants | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 96 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 48 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 48 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 48 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 96 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 96 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 96 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 96 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Change From Baseline in CD4 Cell Count at Week 48 | The change from baseline in CD4 cell count at Week 48 was calculated. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 48 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Mean | 95% Confidence Interval | Cells/mm^3 | | Baseline (Day 1) and Week 48 | | | | ID | Title | Description |
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| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Change From Baseline in CD4 Cell Count at Week 96 | The change from baseline in CD4 cell count at Week 96 was calculated. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 96 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Mean | 95% Confidence Interval | Cells/mm^3 | | Baseline (Day 1) and Week 96 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Secondary | Time to Loss of Virologic Response | The time to loss of virologic response (TLOVR) was reported. For participants who achieved HIV-1 RNA <50 copies/mL of plasma and subsequently had two consecutive HIV-1 RNA values of ≥50 copies/mL measured at least 1 week apart, TLOVR was the time between Day 1 and the date of the first of the two consecutive values ≥50 copies/mL. For participants who achieved and sustained HIV-1 RNA <50 copies/mL, time to loss of virologic response was censored at the time of the last available measurement. | All participants who experienced protocol-defined virologic failure, received ≥1 dose of MK-1439A, had baseline and later data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. Participants who did not experience virologic failure were excluded from the analysis population. | Posted | | Mean | Full Range | Days | | Up to Week 96 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Other Pre-specified | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <50 Copies/mL of Plasma at Week 192 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <50 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
| |
| Other Pre-specified | Percentage of Participants Achieving HIV-1 Ribonucleic Acid (RNA) <40 Copies/mL of Plasma at Week 192 | The percentage of participants achieving HIV-1 ribonucleic acid (RNA) <40 copies/mL in plasma at Week 192 was calculated. The Abbott RealTime HIV-1 Assay, which has a lower limit of reliable quantification (LoQ) of 40 copies/mL, was used to measure the HIV-1 RNA level in plasma samples obtained at Week 192 visit. Participants with reading below the LoQ were considered to have <40 copies/mL. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for HIV in plasma, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 192 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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| Other Pre-specified | Change From Baseline in CD4 Cell Count at Week 192 | The change from baseline in CD4 cell count at Week 192 was calculated. | All participants who received ≥1 dose of MK-1439A, had baseline and Week 192 data for CD4 cell count, and whose central lab results confirmed the presence of protocol-specified NNRTI transmitted resistance-associated mutations. | Posted | | Mean | 95% Confidence Interval | Cells/mm^3 | | Baseline (Day 1) and Week 192 | | | | ID | Title | Description |
|---|
| OG000 | DOR/3TC/TDF | Treatment-naïve HIV-1 infected participants with NNRTI transmitted resistance-associated mutations were treated with open-label MK-1439A (DOR/3TC/TDF 100mg/300mg/300mg) as a FDC tablet taken once daily by mouth for 96 weeks in the Base Study. In addition, eligible participants continued to receive the same MK-1439A regimen from Week 96 to Week 192 during the optional Extension Study. |
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