| Primary | Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment | Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Discontinuation of Ruxolitinib due to thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity related to study drug
Percent experiencing a safety milestone will be reported. | Analysis was done on participants on the Ruxolitinib arm in the safety analysis population. These were all participants randomized to the Ruxolitinib arm who took at least one dose of Ruxolitinib. | Posted | | Number | | percentage of participants | | Entry to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks |
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| Primary | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5 | Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing a safety milestone will be reported. | Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Number | | percentage of participants | | Entry to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment |
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| Primary | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5 | Events defined as safety milestones are listed below.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive. | Analysis was done in the safety population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Number | | percentage of participants | | Entry to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 |
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| Primary | Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm | Number of participants with premature discontinuation of study treatment are summarized. | All participants on the Ruxolitinib arm are included. | Posted | | Count of Participants | | Participants | | Entry to Week 5 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks |
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| Primary | Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5 | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Pre-entry, Entry, Weeks 4 and 5 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up | Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Discontinuation of Ruxolitinib due to thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity related to study drug
Percent experiencing a safety milestone will be reported. | Analysis was done on participants on the Ruxolitinib arm in the safety analysis population. These were all participants randomized to the Ruxolitinib arm who took at least one dose of Ruxolitinib. | Posted | | Number | | percentage of participants | | Entry to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks |
| |
| Secondary | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12 | Events defined as safety milestones are listed below and together makeup the composite endpoint.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm^3 (for participants with entry CD4+ T cell count < 700 cells/mm^3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm^3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing a safety milestone will be reported. | Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Number | | percentage of participants | | Entry to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment |
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| Secondary | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | Events defined as safety milestones are listed below.
- Confirmed CD4+ decline > 33% of entry and to < 350 cell/mm3 (for participants with entry CD4+ T cell count < 700 cells/mm3)
- Confirmed CD4+ decline > 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3)
- Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART
- New or recurrent CDC category C AIDS-indicator condition
- HIV-1 associated infection including Herpes zoster
- Lymphoproliferative malignancies
- Grade 4 or recurrence of Grade 3 anemia/neutropenia
- New diagnosis of pneumonia, sepsis, or bacteremia
- Occurrence of Grade 2 or higher thrombocytopenia
- Any Grade 4 or recurrence of Grade 3 toxicity
Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive. | Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Number | | percentage of participants | | Entry to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 |
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| Secondary | Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point. | Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual. This is a subset of the events reported in the Adverse Events section. | Analysis was done in the safety analysis population. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Count of Participants | | Participants | | Entry to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Creatinine Clearance | Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | mL/min | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Creatinine Clearance Values From Entry | Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | mL/min | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Creatinine | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | mg/dL | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Creatinine Values From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | mL/min | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Absolute Neutrophil Count (ANC) | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Absolute Neutrophil Count (ANC) Values From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Hemoglobin | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | g/dL | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Hemoglobin Values From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | g/dL | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Platelet Count | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | Platelets/mm^3 | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Platelet Counts From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | Platelets/mm^3 | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Aspartate Aminotransferase (AST) (SGOT) | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | U/L | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | U/L | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Alanine Aminotransferase (ALT) (SGPT) | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | U/L | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry. | Analysis was done in the safety analysis population for participants with results available at entry and at the follow-up time point. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Mean | 95% Confidence Interval | U/L | | Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 6 (IL-6) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Pre-entry, Entry, Weeks 4, 5, 10 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
|
| Secondary | Fold Change in the Level of Soluble CD14 (sCD14) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Pre-entry, Entry, Weeks 4, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
|
| Secondary | Change in CD4+ T Cell Count | Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Pre-entry, Entry, Weeks 2, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Count of Participants | | Participants | | Entry, Weeks 2, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL | HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA <0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5). | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Relative Risk | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 7 (IL-7) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha) | Laboratory testing was not performed so the data are not available. | | Posted | | | | | | Pre-entry, Entry, Weeks 4, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10) | Laboratory testing was not performed so the data are not available. | | Posted | | | | | | Pre-entry, Entry, Weeks 4, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Macrophage Colony-stimulating Factor | Laboratory testing was not performed so the data are not available. | | Posted | | | | | | Pre-entry, Entry, Weeks 4, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Neopterin | Data not available because the testing lab reported that the values were unreliable. | | Posted | | | | | | Pre-entry, Entry, Weeks 4, 5, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 10 (IL-10) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 15 (IL-15) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Interleukin 18 (IL-18) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3) | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) CD38+HLADR+ | Absolute change in the percent of parent cells (CD4+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) CD38+HLADR+ | Absolute change in the percent of parent cells (CD8+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) CD25hi+ | Absolute change in the percent of parent cells (CD4+) that express CD25hi+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) CD25+ | Absolute change in the percent of parent cells (CD8+) that express CD25+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) CD127+ | Absolute change in the percent of parent cells (CD4+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) CD127+ | Absolute change in the percent of parent cells (CD8+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) Ki67+ | Absolute change in the percent of parent cells (CD4+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) Ki67+ | Absolute change in the percent of parent cells (CD8+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) Bcl2+ | Absolute change in the percent of parent cells (CD4+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) Bcl2+ | Absolute change in the percent of parent cells (CD8+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD4+) a4b7+ | Absolute change in the percent of parent cells (CD4+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) a4b7+ | Absolute change in the percent of parent cells (CD8+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in (CD3+CD4+) CX3CR1+ | Absolute change in the percent of parent cells (CD4+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in (CD3+CD8+) CX3CR1+ | Absolute change in the percent of parent cells (CD8+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in CD69 | Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69. | | Posted | | | | | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in PAR-1 | Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1. | | Posted | | | | | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Classical Monocytes (CD14+CD16-) | Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Absolute change in the percent of classical monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Absolute change in the percent of classical monocytes (CD14+CD16-) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Absolute change in the percent of classical monocytes (CD14+CD16-) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Inflammatory Monocytes (CD14+CD16+) | Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Absolute change in the percent of inflammatory monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Change in Patrolling Monocytes (CD14dimCD16+) | Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Secondary | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry. | As-treated population w/ results at each time point (data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Mean | 95% Confidence Interval | Percent of Expression in Parent Cell | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Fold Change in Cellular HIV-1 DNA | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Fold Change in Cellular HIV-1 Total RNA | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Percentage of Participants With Detectable CMV Shedding | Level of CMV shedding was summarized by study week and arm as the percentage of those above and below the assay limit of detection. Detectable CMV shedding was defined as CMV level > 0 copies/ml of elution. The percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) was contrasted between study arms. | Analysis was done in the safety analysis population for participants with available data. The safety analysis population includes all participants randomized to the No Study Treatment arm and all participants who took at least one dose of Ruxolitinib among those randomized to the Ruxolitinib arm. | Posted | | Number | | percentage of participants | | Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Secondary | Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK) | Ruxolitinib plasma concentrations were fitted to a population 2-compartment distribution model, assuming first-order input, distribution and elimination from the plasma compartment, using nonlinear mixed-effects modeling software. We estimated parameter geometric means and proportional variabilities between subjects (IIV when feasible) and the variability in drug absorption between occasions (IOV week 1 and week 4/5), and related distribution volumes to body weight. | Analysis was done on participants on the Ruxolitinib arm with intensive pharmacokinetic (PK) results. One participant was not included due to missing samples. | Posted | | Geometric Mean | Geometric Coefficient of Variation | L/hr | | Week 1 and, Week 4/5; blood samples were drawn pre-dose and at 1-1.5, 2.5-4, 4-6, and 6-8 hours post-dosing | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks |
| |
| Other Pre-specified | Change in 2 Long-terminal Repeat Sequences [LTRs] | Data not available because all values were below assay limit. | | Posted | | | | | | Entry, Week 5, and Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
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| Other Pre-specified | Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8) | Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant. | | Posted | | | | | | Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |
| Other Pre-specified | Fold Change in Integrated DNA | All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry. | Analysis was done in the as-treated population (had data at baseline and week 4/5; for the Ruxolitinib arm, remained on study treatment through week 4/5 and missed no more than 6 doses cumulatively; did not change ART, use prohibited medications, or have confirmed virologic failure through week 4/5; not found to be ineligible after randomization). | Posted | | Geometric Mean | 95% Confidence Interval | Fold Change | | Entry, Weeks 5 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Arm A: Ruxolitinib | Participants received ruxolitinib twice a day for 5 weeks. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. Ruxolitinib: 10 mg orally twice daily for 5 weeks | | OG001 | Arm B: No Study Treatment | Participants did not receive any study treatment. Participants were required to remain on ART regimen (not provided by the study) for the duration of the study. |
| |