Trial Outcomes & Findings for Evaluating the Safety and Tolerability of Ruxolitinib in Antiretroviral-Treated HIV-Infected Adults (NCT NCT02475655)
NCT ID: NCT02475655
Last Updated: 2021-11-04
Results Overview
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.
COMPLETED
PHASE2
60 participants
Entry to Week 5
2021-11-04
Participant Flow
Enrollment began in 05/2016 and completed in 01/2018. Of N=119 screened subjects, N=60 were enrolled from fourteen clinical research sites in the United States.
Enrollment was stratified based on whether a participant was on an EFV-containing regimen.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
20
|
|
Overall Study
COMPLETED
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
2 participants were missing race/ethnicity.
Baseline characteristics by cohort
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49 years
n=40 Participants
|
43.5 years
n=20 Participants
|
49 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=40 Participants
|
4 Participants
n=20 Participants
|
12 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=40 Participants
|
16 Participants
n=20 Participants
|
48 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White Non-Hispanic
|
14 Participants
n=38 Participants • 2 participants were missing race/ethnicity.
|
7 Participants
n=20 Participants • 2 participants were missing race/ethnicity.
|
21 Participants
n=58 Participants • 2 participants were missing race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black Non-Hispanic
|
19 Participants
n=38 Participants • 2 participants were missing race/ethnicity.
|
10 Participants
n=20 Participants • 2 participants were missing race/ethnicity.
|
29 Participants
n=58 Participants • 2 participants were missing race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic (Regardless of Race)
|
4 Participants
n=38 Participants • 2 participants were missing race/ethnicity.
|
2 Participants
n=20 Participants • 2 participants were missing race/ethnicity.
|
6 Participants
n=58 Participants • 2 participants were missing race/ethnicity.
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than One Race
|
1 Participants
n=38 Participants • 2 participants were missing race/ethnicity.
|
1 Participants
n=20 Participants • 2 participants were missing race/ethnicity.
|
2 Participants
n=58 Participants • 2 participants were missing race/ethnicity.
|
|
Region of Enrollment
United States
|
40 Participants
n=40 Participants
|
20 Participants
n=20 Participants
|
60 Participants
n=60 Participants
|
|
Weight
|
89.2 kg
n=40 Participants
|
91.0 kg
n=20 Participants
|
89.2 kg
n=60 Participants
|
|
BMI
|
29.2 kg/m^2
n=40 Participants
|
29.5 kg/m^2
n=20 Participants
|
29.2 kg/m^2
n=60 Participants
|
|
Entry CD4 Count
|
798 cells/mm^3
n=40 Participants
|
737 cells/mm^3
n=20 Participants
|
791 cells/mm^3
n=60 Participants
|
|
Baseline CD4 Count
|
816 cells/mm^3
n=40 Participants
|
855 cells/mm^3
n=20 Participants
|
844 cells/mm^3
n=60 Participants
|
|
HIV-1 RNA
<40 copies/mL
|
39 Participants
n=40 Participants
|
20 Participants
n=20 Participants
|
59 Participants
n=60 Participants
|
|
HIV-1 RNA
>=40 copies/mL
|
1 Participants
n=40 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=60 Participants
|
|
Baseline Interleukin 6 (IL-6)
|
1.90 pg/mL
STANDARD_DEVIATION 1.84 • n=37 Participants • Only reported 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).
|
1.69 pg/mL
STANDARD_DEVIATION 1.68 • n=18 Participants • Only reported 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).
|
1.83 pg/mL
STANDARD_DEVIATION 1.79 • n=55 Participants • Only reported 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).
|
PRIMARY outcome
Timeframe: Entry to Week 5Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
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.
|
|---|---|---|
|
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment
|
2.5 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Entry to Week 5Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5
|
2.5 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Entry to Week 5Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Confirmed CD4+ decline > 33% of entry
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Confirmed CD4+ decline > 50% of entry
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Confirmed HIV-1 RNA level above the lower limit
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
New/recurrent category C AIDS-indicator condition
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
HIV-1 associated infection including Herpes zoster
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Lymphoproliferative malignancies
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Grade 4/ recurrence of Grade 3 anemia/neutropenia
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
New diagnosis of pneumonia, sepsis, or bacteremia
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Occurrence of Grade 2 or higher thrombocytopenia
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Any Grade 4 or recurrence of Grade 3 toxicity
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Entry to Week 5Population: All participants on the Ruxolitinib arm are included.
Number of participants with premature discontinuation of study treatment are summarized.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
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.
|
|---|---|---|
|
Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm
|
3 Participants
|
—
|
PRIMARY outcome
Timeframe: Pre-entry, Entry, Weeks 4 and 5Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=37 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5
|
0.93 Fold Change
Interval 0.82 to 1.06
|
1.10 Fold Change
Interval 0.84 to 1.44
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
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.
|
|---|---|---|
|
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up
|
7.5 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12
|
7.5 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Confirmed CD4+ decline > 33% of entry
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Confirmed CD4+ decline > 50% of entry
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Confirmed HIV-1 RNA level above the lower limit
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
New/recurrent category C AIDS-indicator condition
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
HIV-1 associated infection including Herpes zoster
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Lymphoproliferative malignancies
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Grade 4/ recurrence of Grade 3 anemia/neutropenia
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
New diagnosis of pneumonia, sepsis, or bacteremia
|
2.5 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Occurrence of Grade 2 or higher thrombocytopenia
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Any Grade 4 or recurrence of Grade 3 toxicity
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Entry to Week 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Creatinine Clearance
Week 10/12
|
117.8 mL/min
Interval 108.3 to 127.2
|
126.6 mL/min
Interval 107.4 to 145.9
|
|
Creatinine Clearance
Entry
|
118.5 mL/min
Interval 107.8 to 129.1
|
134.5 mL/min
Interval 115.4 to 153.6
|
|
Creatinine Clearance
Week 1/2
|
116.3 mL/min
Interval 106.6 to 126.0
|
130.2 mL/min
Interval 110.3 to 150.1
|
|
Creatinine Clearance
Week 4/5
|
117.3 mL/min
Interval 106.3 to 128.3
|
130.9 mL/min
Interval 111.5 to 150.4
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Creatinine Clearance Values From Entry
Change From Entry to Week 1/2
|
-2.16 mL/min
Interval -5.97 to 1.65
|
-3.47 mL/min
Interval -9.34 to 2.4
|
|
Change in Creatinine Clearance Values From Entry
Change From Entry to Week 4/5
|
-1.17 mL/min
Interval -6.0 to 3.66
|
-2.78 mL/min
Interval -8.81 to 3.24
|
|
Change in Creatinine Clearance Values From Entry
Change From Entry to Week 10/12
|
-0.71 mL/min
Interval -5.07 to 3.65
|
-7.06 mL/min
Interval -13.1 to -1.04
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Creatinine
Entry
|
0.99 mg/dL
Interval 0.93 to 1.05
|
0.92 mg/dL
Interval 0.85 to 0.99
|
|
Creatinine
Week 1/2
|
1.0 mg/dL
Interval 0.94 to 1.06
|
0.95 mg/dL
Interval 0.87 to 1.03
|
|
Creatinine
Week 4/5
|
1.01 mg/dL
Interval 0.94 to 1.07
|
0.95 mg/dL
Interval 0.87 to 1.02
|
|
Creatinine
Week 10/12
|
0.99 mg/dL
Interval 0.93 to 1.04
|
0.99 mg/dL
Interval 0.91 to 1.06
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Creatinine Values From Entry
Change From Entry to Week 1/2
|
0.01 mL/min
Interval -0.02 to 0.05
|
0.03 mL/min
Interval -0.01 to 0.07
|
|
Change in Creatinine Values From Entry
Change From Entry to Week 4/5
|
0.02 mL/min
Interval -0.02 to 0.05
|
0.03 mL/min
Interval -0.02 to 0.07
|
|
Change in Creatinine Values From Entry
Change From Entry to Week 10/12
|
-0.00 mL/min
Interval -0.04 to 0.03
|
0.07 mL/min
Interval 0.03 to 0.1
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Absolute Neutrophil Count (ANC)
Entry
|
3558 cells/mm^3
Interval 3049.0 to 4068.0
|
2730 cells/mm^3
Interval 2244.0 to 3216.0
|
|
Absolute Neutrophil Count (ANC)
Week 1/2
|
3390 cells/mm^3
Interval 2879.0 to 3901.0
|
3312 cells/mm^3
Interval 2583.0 to 4041.0
|
|
Absolute Neutrophil Count (ANC)
Week 4/5
|
3307 cells/mm^3
Interval 2834.0 to 3780.0
|
3163 cells/mm^3
Interval 2434.0 to 3891.0
|
|
Absolute Neutrophil Count (ANC)
Week 10/12
|
3857 cells/mm^3
Interval 3252.0 to 4462.0
|
3067 cells/mm^3
Interval 2494.0 to 3639.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Absolute Neutrophil Count (ANC) Values From Entry
Change From Entry to Week 4/5
|
-251 cells/mm^3
Interval -506.0 to 3.7
|
400 cells/mm^3
Interval -233.0 to 1033.0
|
|
Change in Absolute Neutrophil Count (ANC) Values From Entry
Change From Entry to Week 10/12
|
299 cells/mm^3
Interval -29.7 to 627.0
|
265 cells/mm^3
Interval -280.0 to 810.0
|
|
Change in Absolute Neutrophil Count (ANC) Values From Entry
Change From Entry to Week 1/2
|
-169 cells/mm^3
Interval -476.0 to 138.9
|
510 cells/mm^3
Interval -11.6 to 1032.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Hemoglobin
Entry
|
14.3 g/dL
Interval 13.8 to 14.8
|
14.3 g/dL
Interval 13.8 to 14.7
|
|
Hemoglobin
Week 1/2
|
14.0 g/dL
Interval 13.6 to 14.4
|
14.1 g/dL
Interval 13.6 to 14.7
|
|
Hemoglobin
Week 4/5
|
13.6 g/dL
Interval 13.2 to 14.1
|
14.2 g/dL
Interval 13.6 to 14.8
|
|
Hemoglobin
Week 10/12
|
14.4 g/dL
Interval 13.7 to 15.0
|
14.2 g/dL
Interval 13.7 to 14.7
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin Values From Entry
Change From Entry to Week 1/2
|
-0.28 g/dL
Interval -0.48 to -0.08
|
-0.15 g/dL
Interval -0.44 to 0.14
|
|
Change in Hemoglobin Values From Entry
Change From Entry to Week 4/5
|
-0.65 g/dL
Interval -0.88 to -0.42
|
-0.10 g/dL
Interval -0.39 to 0.2
|
|
Change in Hemoglobin Values From Entry
Change From Entry to Week 10/12
|
-0.07 g/dL
Interval -0.58 to 0.73
|
-0.08 g/dL
Interval -0.35 to 0.19
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Platelet Count
Entry
|
238508 Platelets/mm^3
Interval 222160.0 to 254855.0
|
261868 Platelets/mm^3
Interval 237968.0 to 285769.0
|
|
Platelet Count
Week 1/2
|
281525 Platelets/mm^3
Interval 261316.0 to 301734.0
|
264492 Platelets/mm^3
Interval 233571.0 to 295413.0
|
|
Platelet Count
Week 4/5
|
270943 Platelets/mm^3
Interval 252682.0 to 289203.0
|
264155 Platelets/mm^3
Interval 235979.0 to 292332.0
|
|
Platelet Count
Week 10/12
|
247323 Platelets/mm^3
Interval 230033.0 to 264612.0
|
261184 Platelets/mm^3
Interval 231331.0 to 291038.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Platelet Counts From Entry
Change From Entry to Week 1/2
|
43018 Platelets/mm^3
Interval 30682.0 to 55353.0
|
5264 Platelets/mm^3
Interval -13341.0 to 23868.0
|
|
Change in Platelet Counts From Entry
Change From Entry to Week 4/5
|
32435 Platelets/mm^3
Interval 19716.0 to 45154.0
|
4603 Platelets/mm^3
Interval -11880.0 to 21086.0
|
|
Change in Platelet Counts From Entry
Change From Entry to Week 10/12
|
8815 Platelets/mm^3
Interval 301.0 to 17329.0
|
3439 Platelets/mm^3
Interval -13976.0 to 20853.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Aspartate Aminotransferase (AST) (SGOT)
Entry
|
23.2 U/L
Interval 20.6 to 25.7
|
23.1 U/L
Interval 19.2 to 26.9
|
|
Aspartate Aminotransferase (AST) (SGOT)
Week 1/2
|
28.2 U/L
Interval 24.1 to 32.2
|
23.5 U/L
Interval 18.1 to 28.9
|
|
Aspartate Aminotransferase (AST) (SGOT)
Week 4/5
|
29.1 U/L
Interval 25.2 to 32.9
|
21.2 U/L
Interval 18.5 to 23.9
|
|
Aspartate Aminotransferase (AST) (SGOT)
Week 10/12
|
24.7 U/L
Interval 22.0 to 27.3
|
21.0 U/L
Interval 18.2 to 23.8
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
Change From Entry to Week 10/12
|
1.48 U/L
Interval -0.45 to 3.4
|
-2.47 U/L
Interval -5.58 to 0.63
|
|
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
Change From Entry to Week 1/2
|
5.01 U/L
Interval 2.17 to 7.86
|
0.05 U/L
Interval -4.35 to 4.45
|
|
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
Change From Entry to Week 4/5
|
5.89 U/L
Interval 3.16 to 8.61
|
-2.26 U/L
Interval -5.32 to 0.79
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Alanine Aminotransferase (ALT) (SGPT)
Week 10/12
|
24.9 U/L
Interval 21.7 to 28.2
|
23.2 U/L
Interval 18.6 to 27.7
|
|
Alanine Aminotransferase (ALT) (SGPT)
Entry
|
24.3 U/L
Interval 21.0 to 27.6
|
26.9 U/L
Interval 20.2 to 33.5
|
|
Alanine Aminotransferase (ALT) (SGPT)
Week 1/2
|
28.5 U/L
Interval 24.5 to 32.6
|
26.5 U/L
Interval 18.7 to 34.2
|
|
Alanine Aminotransferase (ALT) (SGPT)
Week 4/5
|
30.6 U/L
Interval 24.9 to 36.2
|
22.4 U/L
Interval 18.1 to 26.7
|
SECONDARY outcome
Timeframe: Entry, Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
Change From Entry to Week 4/5
|
6.25 U/L
Interval 1.61 to 10.9
|
-4.74 U/L
Interval -9.45 to -0.03
|
|
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
Change From Entry to Week 10/12
|
0.64 U/L
Interval -1.72 to 2.99
|
-4.00 U/L
Interval -8.52 to 0.52
|
|
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
Change From Entry to Week 1/2
|
4.21 U/L
Interval 1.62 to 6.81
|
-0.68 U/L
Interval -3.3 to 1.94
|
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, 10 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
Fold Change from Baseline to Week 10/12
|
1.16 Fold Change
Interval 0.96 to 1.41
|
1.06 Fold Change
Interval 0.82 to 1.36
|
|
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
Fold Change from Week 4/5 to Week 10/12
|
1.26 Fold Change
Interval 1.06 to 1.49
|
0.92 Fold Change
Interval 0.76 to 1.11
|
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=37 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Soluble CD14 (sCD14)
Fold Change from Baseline to Week 4/5
|
0.96 Fold Change
Interval 0.9 to 1.02
|
1.08 Fold Change
Interval 0.93 to 1.26
|
|
Fold Change in the Level of Soluble CD14 (sCD14)
Fold Change from Baseline to Week 12
|
1.02 Fold Change
Interval 0.91 to 1.15
|
1.08 Fold Change
Interval 0.93 to 1.25
|
|
Fold Change in the Level of Soluble CD14 (sCD14)
Fold Change from Week 4/5 to Week 12
|
1.08 Fold Change
Interval 0.96 to 1.2
|
1.02 Fold Change
Interval 0.86 to 1.21
|
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 2, 5, and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=37 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Change in CD4+ T Cell Count
Change from Baseline to Week 2
|
131.2 cells/mm^3
Interval 66.6 to 195.8
|
-10.9 cells/mm^3
Interval -75.0 to 53.3
|
|
Change in CD4+ T Cell Count
Change from Baseline to Week 5
|
66.1 cells/mm^3
Interval 0.87 to 131.2
|
-8.19 cells/mm^3
Interval -64.1 to 47.7
|
|
Change in CD4+ T Cell Count
Change from Baseline to Week 12
|
3.27 cells/mm^3
Interval -76.4 to 82.9
|
42.2 cells/mm^3
Interval -45.6 to 130.0
|
|
Change in CD4+ T Cell Count
Change from Week 5 to Week 12
|
-62.1 cells/mm^3
Interval -153.0 to 28.9
|
50.4 cells/mm^3
Interval -46.2 to 146.9
|
SECONDARY outcome
Timeframe: Entry, Weeks 2, 5, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Week 5
|
2 Participants
|
0 Participants
|
|
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Entry
|
1 Participants
|
0 Participants
|
|
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Week 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Week 12
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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).
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=37 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
Relative risk of SCA<LOD at Wk 5 compared to Entry
|
1.20 Relative Risk
Interval 0.84 to 1.72
|
1.22 Relative Risk
Interval 0.82 to 1.81
|
|
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
Relative risk of SCA<LOD at Wk12 compared to Entry
|
0.82 Relative Risk
Interval 0.44 to 1.53
|
1.11 Relative Risk
Interval 0.64 to 1.92
|
|
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
Relative risk of SCA<LOD at Wk12 compared to Wk5
|
0.75 Relative Risk
Interval 0.43 to 1.32
|
0.91 Relative Risk
Interval 0.6 to 1.38
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
Fold Change from Entry to Week 5
|
0.79 Fold Change
Interval 0.71 to 0.88
|
0.90 Fold Change
Interval 0.82 to 0.99
|
|
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
Fold Change from Entry to Week 12
|
0.85 Fold Change
Interval 0.63 to 1.14
|
0.92 Fold Change
Interval 0.73 to 1.15
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
Fold Change from Entry to Week 12
|
1.24 Fold Change
Interval 0.6 to 2.6
|
0.78 Fold Change
Interval 0.28 to 2.21
|
|
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
Fold Change from Entry to Week 5
|
0.96 Fold Change
Interval 0.72 to 1.27
|
0.75 Fold Change
Interval 0.55 to 1.03
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
Fold Change from Entry to Week 5
|
1.04 Fold Change
Interval 0.82 to 1.33
|
0.81 Fold Change
Interval 0.55 to 1.18
|
|
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
Fold Change from Entry to Week 12
|
1.23 Fold Change
Interval 0.92 to 1.65
|
1.04 Fold Change
Interval 0.76 to 1.42
|
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, and 12Population: Results not reported.
Laboratory testing was not performed so the data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, and 12Population: Results not reported.
Laboratory testing was not performed so the data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, and 12Population: Results not reported.
Laboratory testing was not performed so the data are not available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-entry, Entry, Weeks 4, 5, and 12Population: Results not reported.
Data not available because the testing lab reported that the values were unreliable.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
Fold Change from Entry to Week 5
|
0.94 Fold Change
Interval 0.75 to 1.17
|
0.82 Fold Change
Interval 0.47 to 1.43
|
|
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
Fold Change from Entry to Week 12
|
0.65 Fold Change
Interval 0.37 to 1.15
|
0.67 Fold Change
Interval 0.39 to 1.16
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
Fold Change from Entry to Week 5
|
1.33 Fold Change
Interval 1.19 to 1.48
|
0.99 Fold Change
Interval 0.87 to 1.13
|
|
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
Fold Change from Entry to Week 12
|
1.06 Fold Change
Interval 0.88 to 1.27
|
0.98 Fold Change
Interval 0.87 to 1.11
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
Fold Change from Entry to Week 5
|
0.89 Fold Change
Interval 0.81 to 0.98
|
0.95 Fold Change
Interval 0.84 to 1.07
|
|
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
Fold Change from Entry to Week 12
|
1.05 Fold Change
Interval 0.88 to 1.24
|
1.02 Fold Change
Interval 0.9 to 1.15
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
Fold Change from Entry to Week 5
|
0.90 Fold Change
Interval 0.74 to 1.11
|
0.60 Fold Change
Interval 0.44 to 0.83
|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
Fold Change from Entry to Week 12
|
1.91 Fold Change
Interval 0.86 to 4.22
|
0.93 Fold Change
Interval 0.71 to 1.24
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
Fold Change from Entry to Week 5
|
0.96 Fold Change
Interval 0.81 to 1.13
|
0.69 Fold Change
Interval 0.52 to 0.9
|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
Fold Change from Entry to Week 12
|
0.90 Fold Change
Interval 0.49 to 1.65
|
0.94 Fold Change
Interval 0.62 to 1.41
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
Fold Change from Entry to Week 12
|
0.67 Fold Change
Interval 0.39 to 1.16
|
0.99 Fold Change
Interval 0.42 to 2.36
|
|
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
Fold Change from Entry to Week 5
|
0.99 Fold Change
Interval 0.52 to 1.9
|
0.63 Fold Change
Interval 0.23 to 1.69
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) CD38+HLADR+
Change from Entry to Week 5
|
-0.27 Percent of Expression in Parent Cell
Interval -0.47 to -0.07
|
0.08 Percent of Expression in Parent Cell
Interval -0.18 to 0.33
|
|
Change in (CD3+CD4+) CD38+HLADR+
Change from Entry to Week 12
|
0.17 Percent of Expression in Parent Cell
Interval 0.01 to 0.32
|
-0.10 Percent of Expression in Parent Cell
Interval -0.38 to 0.18
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) CD38+HLADR+
Change from Entry to Week 5
|
-1.16 Percent of Expression in Parent Cell
Interval -1.67 to -0.65
|
-0.28 Percent of Expression in Parent Cell
Interval -1.09 to 0.53
|
|
Change in (CD3+CD8+) CD38+HLADR+
Change from Entry to Week 12
|
0.89 Percent of Expression in Parent Cell
Interval 0.16 to 1.62
|
0.03 Percent of Expression in Parent Cell
Interval -0.94 to 1.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) CD25hi+
Change from Entry to Week 5
|
-1.50 Percent of Expression in Parent Cell
Interval -1.95 to -1.05
|
0.22 Percent of Expression in Parent Cell
Interval -0.74 to 1.18
|
|
Change in (CD3+CD4+) CD25hi+
Change from Entry to Week 12
|
0.08 Percent of Expression in Parent Cell
Interval -0.37 to 0.53
|
-0.08 Percent of Expression in Parent Cell
Interval -0.79 to 0.62
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) CD25+
Change from Entry to Week 5
|
-0.31 Percent of Expression in Parent Cell
Interval -0.85 to 0.22
|
-0.31 Percent of Expression in Parent Cell
Interval -0.83 to 0.22
|
|
Change in (CD3+CD8+) CD25+
Change from Entry to Week 12
|
-0.53 Percent of Expression in Parent Cell
Interval -1.25 to 0.19
|
-0.38 Percent of Expression in Parent Cell
Interval -1.23 to 0.48
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) CD127+
Change from Entry to Week 5
|
2.65 Percent of Expression in Parent Cell
Interval 1.33 to 3.97
|
-0.84 Percent of Expression in Parent Cell
Interval -2.24 to 0.57
|
|
Change in (CD3+CD4+) CD127+
Change from Entry to Week 12
|
-1.48 Percent of Expression in Parent Cell
Interval -2.94 to -0.03
|
-0.19 Percent of Expression in Parent Cell
Interval -1.97 to 1.6
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) CD127+
Change from Entry to Week 5
|
5.42 Percent of Expression in Parent Cell
Interval 3.44 to 7.4
|
-1.12 Percent of Expression in Parent Cell
Interval -3.86 to 1.63
|
|
Change in (CD3+CD8+) CD127+
Change from Entry to Week 12
|
-0.09 Percent of Expression in Parent Cell
Interval -2.53 to 2.35
|
0.11 Percent of Expression in Parent Cell
Interval -3.05 to 3.26
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) Ki67+
Change from Entry to Week 5
|
-0.26 Percent of Expression in Parent Cell
Interval -0.55 to 0.02
|
-0.19 Percent of Expression in Parent Cell
Interval -0.95 to 0.58
|
|
Change in (CD3+CD4+) Ki67+
Change from Entry to Week 12
|
0.37 Percent of Expression in Parent Cell
Interval 0.0 to 0.73
|
-0.39 Percent of Expression in Parent Cell
Interval -1.11 to 0.32
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) Ki67+
Change from Entry to Week 5
|
-0.64 Percent of Expression in Parent Cell
Interval -0.88 to -0.41
|
-0.65 Percent of Expression in Parent Cell
Interval -1.5 to 0.19
|
|
Change in (CD3+CD8+) Ki67+
Change from Entry to Week 12
|
0.59 Percent of Expression in Parent Cell
Interval -0.03 to 1.21
|
0.04 Percent of Expression in Parent Cell
Interval -1.26 to 1.33
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) Bcl2+
Change from Entry to Week 5
|
-3.77 Percent of Expression in Parent Cell
Interval -4.93 to -2.62
|
-0.48 Percent of Expression in Parent Cell
Interval -1.31 to 0.35
|
|
Change in (CD3+CD4+) Bcl2+
Change from Entry to Week 12
|
-0.67 Percent of Expression in Parent Cell
Interval -1.11 to -0.23
|
0.06 Percent of Expression in Parent Cell
Interval -0.81 to 0.92
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) Bcl2+
Change from Entry to Week 5
|
-5.64 Percent of Expression in Parent Cell
Interval -7.19 to -4.09
|
-0.24 Percent of Expression in Parent Cell
Interval -1.2 to 0.72
|
|
Change in (CD3+CD8+) Bcl2+
Change from Entry to Week 12
|
-1.29 Percent of Expression in Parent Cell
Interval -2.14 to -0.44
|
-0.06 Percent of Expression in Parent Cell
Interval -1.5 to 1.38
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) a4b7+
Change from Entry to Week 5
|
-2.16 Percent of Expression in Parent Cell
Interval -3.43 to -0.88
|
-0.62 Percent of Expression in Parent Cell
Interval -3.64 to 2.4
|
|
Change in (CD3+CD4+) a4b7+
Change from Entry to Week 12
|
-0.01 Percent of Expression in Parent Cell
Interval -1.45 to 1.43
|
0.38 Percent of Expression in Parent Cell
Interval -1.58 to 2.34
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=34 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) a4b7+
Change from Entry to Week 5
|
0.01 Percent of Expression in Parent Cell
Interval -1.62 to 1.65
|
-0.54 Percent of Expression in Parent Cell
Interval -3.3 to 2.22
|
|
Change in (CD3+CD8+) a4b7+
Change from Entry to Week 12
|
0.91 Percent of Expression in Parent Cell
Interval -0.8 to 2.61
|
0.59 Percent of Expression in Parent Cell
Interval -1.99 to 3.18
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD4+) CX3CR1+
Change from Entry to Week 5
|
-1.55 Percent of Expression in Parent Cell
Interval -2.14 to -0.96
|
-0.22 Percent of Expression in Parent Cell
Interval -1.0 to 0.56
|
|
Change in (CD3+CD4+) CX3CR1+
Change from Entry to Week 12
|
-0.21 Percent of Expression in Parent Cell
Interval -0.66 to 0.24
|
-0.04 Percent of Expression in Parent Cell
Interval -1.26 to 1.19
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in (CD3+CD8+) CX3CR1+
Change from Entry to Week 5
|
-4.31 Percent of Expression in Parent Cell
Interval -5.46 to -3.16
|
-1.07 Percent of Expression in Parent Cell
Interval -3.71 to 1.57
|
|
Change in (CD3+CD8+) CX3CR1+
Change from Entry to Week 12
|
-0.39 Percent of Expression in Parent Cell
Interval -1.79 to 1.02
|
-0.22 Percent of Expression in Parent Cell
Interval -2.87 to 2.43
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: Results not reported.
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: Results not reported.
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Classical Monocytes (CD14+CD16-)
Change from Entry to Week 5
|
0.95 Percent of Expression in Parent Cell
Interval -1.49 to 3.4
|
-0.43 Percent of Expression in Parent Cell
Interval -2.66 to 1.8
|
|
Change in Classical Monocytes (CD14+CD16-)
Change from Entry to Week 12
|
1.15 Percent of Expression in Parent Cell
Interval -0.85 to 3.15
|
-1.06 Percent of Expression in Parent Cell
Interval -4.27 to 2.15
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CD163+
Change from Entry to Week 12
|
-5.05 Percent of Expression in Parent Cell
Interval -9.68 to -0.43
|
4.76 Percent of Expression in Parent Cell
Interval -2.36 to 11.9
|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CD163+
Change from Entry to Week 5
|
-1.16 Percent of Expression in Parent Cell
Interval -5.47 to 3.15
|
3.18 Percent of Expression in Parent Cell
Interval -4.62 to 11.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+
Change from Entry to Week 5
|
-1.24 Percent of Expression in Parent Cell
Interval -2.83 to 0.35
|
-0.43 Percent of Expression in Parent Cell
Interval -2.44 to 1.58
|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+
Change from Entry to Week 12
|
-0.84 Percent of Expression in Parent Cell
Interval -1.77 to 0.09
|
0.86 Percent of Expression in Parent Cell
Interval -1.43 to 3.15
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+
Change from Entry to Week 5
|
-1.72 Percent of Expression in Parent Cell
Interval -2.99 to -0.44
|
-0.25 Percent of Expression in Parent Cell
Interval -1.52 to 1.02
|
|
Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+
Change from Entry to Week 12
|
-0.62 Percent of Expression in Parent Cell
Interval -2.89 to 1.65
|
1.00 Percent of Expression in Parent Cell
Interval -0.96 to 2.96
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Inflammatory Monocytes (CD14+CD16+)
Change from Entry to Week 5
|
-1.21 Percent of Expression in Parent Cell
Interval -2.46 to 0.03
|
-0.36 Percent of Expression in Parent Cell
Interval -1.57 to 0.86
|
|
Change in Inflammatory Monocytes (CD14+CD16+)
Change from Entry to Week 12
|
-0.49 Percent of Expression in Parent Cell
Interval -1.85 to 0.88
|
0.22 Percent of Expression in Parent Cell
Interval -1.44 to 1.88
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+
Change from Entry to Week 5
|
-3.88 Percent of Expression in Parent Cell
Interval -8.29 to 0.53
|
2.14 Percent of Expression in Parent Cell
Interval -2.62 to 6.89
|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+
Change from Entry to Week 12
|
-4.40 Percent of Expression in Parent Cell
Interval -7.97 to -0.82
|
2.00 Percent of Expression in Parent Cell
Interval -1.0 to 4.99
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+
Change from Entry to Week 5
|
2.95 Percent of Expression in Parent Cell
Interval -1.81 to 7.71
|
2.67 Percent of Expression in Parent Cell
Interval -6.4 to 11.7
|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+
Change from Entry to Week 12
|
-1.99 Percent of Expression in Parent Cell
Interval -7.17 to 3.2
|
2.11 Percent of Expression in Parent Cell
Interval -8.76 to 13.0
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+
Change from Entry to Week 5
|
-4.38 Percent of Expression in Parent Cell
Interval -8.56 to -0.2
|
-5.61 Percent of Expression in Parent Cell
Interval -12.6 to 1.4
|
|
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+
Change from Entry to Week 12
|
0.58 Percent of Expression in Parent Cell
Interval -5.47 to 6.63
|
-3.18 Percent of Expression in Parent Cell
Interval -7.12 to 0.76
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Patrolling Monocytes (CD14dimCD16+)
Change from Entry to Week 12
|
-0.70 Percent of Expression in Parent Cell
Interval -2.28 to 0.89
|
0.87 Percent of Expression in Parent Cell
Interval -1.69 to 3.42
|
|
Change in Patrolling Monocytes (CD14dimCD16+)
Change from Entry to Week 5
|
0.20 Percent of Expression in Parent Cell
Interval -1.56 to 1.96
|
0.83 Percent of Expression in Parent Cell
Interval -0.98 to 2.65
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+
Change from Entry to Week 5
|
-4.05 Percent of Expression in Parent Cell
Interval -7.55 to -0.54
|
3.05 Percent of Expression in Parent Cell
Interval -0.27 to 6.37
|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+
Change from Entry to Week 12
|
-1.09 Percent of Expression in Parent Cell
Interval -5.9 to 3.73
|
0.41 Percent of Expression in Parent Cell
Interval -5.06 to 5.88
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+
Change from Entry to Week 5
|
0.02 Percent of Expression in Parent Cell
Interval -0.03 to 0.07
|
0.01 Percent of Expression in Parent Cell
Interval -0.03 to 0.06
|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+
Change from Entry to Week 12
|
0.04 Percent of Expression in Parent Cell
Interval -0.01 to 0.1
|
0.04 Percent of Expression in Parent Cell
Interval -0.03 to 0.1
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=35 Participants
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
|
Arm B: No Study Treatment
n=16 Participants
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.
|
|---|---|---|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+
Change from Entry to Week 5
|
-5.48 Percent of Expression in Parent Cell
Interval -9.38 to -1.59
|
-2.64 Percent of Expression in Parent Cell
Interval -9.44 to 4.17
|
|
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+
Change from Entry to Week 12
|
-2.39 Percent of Expression in Parent Cell
Interval -7.64 to 2.87
|
-2.42 Percent of Expression in Parent Cell
Interval -4.73 to -0.1
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Fold Change in Cellular HIV-1 DNA
Fold Change from Entry to Week 5
|
1.16 Fold Change
Interval 0.96 to 1.41
|
0.62 Fold Change
Interval 0.36 to 1.06
|
|
Fold Change in Cellular HIV-1 DNA
Fold Change from Entry to Week 12
|
1.18 Fold Change
Interval 0.98 to 1.42
|
0.90 Fold Change
Interval 0.52 to 1.55
|
SECONDARY outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=36 Participants
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
|
Arm B: No Study Treatment
n=18 Participants
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.
|
|---|---|---|
|
Fold Change in Cellular HIV-1 Total RNA
Fold Change from Entry to Week 5
|
1.06 Fold Change
Interval 0.82 to 1.38
|
0.87 Fold Change
Interval 0.66 to 1.15
|
|
Fold Change in Cellular HIV-1 Total RNA
Fold Change from Entry to Week 12
|
0.97 Fold Change
Interval 0.74 to 1.29
|
0.95 Fold Change
Interval 0.6 to 1.5
|
SECONDARY outcome
Timeframe: Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12Population: 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.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=40 Participants
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
|
Arm B: No Study Treatment
n=20 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Detectable CMV Shedding
Pre-entry
|
13 percentage of participants
|
5 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Entry
|
13 percentage of participants
|
10 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 1
|
13 percentage of participants
|
11 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 2
|
8 percentage of participants
|
16 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 4
|
8 percentage of participants
|
6 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 5
|
5 percentage of participants
|
16 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 10
|
5 percentage of participants
|
11 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Week 12
|
20 percentage of participants
|
16 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Any Detectable CMV On-treatment
|
18 percentage of participants
|
26 percentage of participants
|
|
Percentage of Participants With Detectable CMV Shedding
Any Detectable CMV Post-treatment
|
20 percentage of participants
|
16 percentage of participants
|
SECONDARY outcome
Timeframe: 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-dosingPopulation: Analysis was done on participants on the Ruxolitinib arm with intensive pharmacokinetic (PK) results. One participant was not included due to missing samples.
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=39 Participants
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
|
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.
|
|---|---|---|
|
Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK)
|
14.5 L/hr
Geometric Coefficient of Variation 34
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Entry, Week 5, and Week 12Population: Results not reported.
Data not available because all values were below assay limit.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12Population: Results not reported.
Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Entry, Weeks 5 and 12Population: 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).
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.
Outcome measures
| Measure |
Arm A: Ruxolitinib
n=33 Participants
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
|
Arm B: No Study Treatment
n=17 Participants
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.
|
|---|---|---|
|
Fold Change in Integrated DNA
Fold Change from Entry to Week 5
|
1.10 Fold Change
Interval 0.44 to 2.71
|
2.06 Fold Change
Interval 0.61 to 6.98
|
|
Fold Change in Integrated DNA
Fold Change from Entry to Week 12
|
1.11 Fold Change
Interval 0.31 to 4.0
|
1.20 Fold Change
Interval 0.43 to 3.36
|
Adverse Events
Ruxolitinib
No Study Treatment
Serious adverse events
| Measure |
Ruxolitinib
n=40 participants at risk
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
|
No Study Treatment
n=20 participants at risk
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.
|
|---|---|---|
|
Eye disorders
Vitreous detachment
|
2.5%
1/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Metabolism and nutrition disorders
Malnutrition
|
2.5%
1/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
Other adverse events
| Measure |
Ruxolitinib
n=40 participants at risk
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
|
No Study Treatment
n=20 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
General disorders
Fatigue
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
General disorders
Pain
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Infections and infestations
Acute sinusitis
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
5/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
10.0%
2/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Aspartate aminotransferase increased
|
20.0%
8/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
10.0%
2/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood cholesterol increased
|
22.5%
9/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
35.0%
7/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood creatinine increased
|
12.5%
5/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
10.0%
2/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood glucose increased
|
17.5%
7/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
15.0%
3/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood phosphorus decreased
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Blood triglycerides increased
|
32.5%
13/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
30.0%
6/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Low density lipoprotein increased
|
17.5%
7/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
40.0%
8/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Investigations
Neutrophil count decreased
|
2.5%
1/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Nervous system disorders
Dizziness
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
0.00%
0/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Nervous system disorders
Headache
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
2/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/40 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
5.0%
1/20 • Week 0 to Week 12
Protocol-defined recorded adverse events include: all diagnoses regardless of grade, Grade 2 or higher sign/symptoms and all non-traumatic bruising; Grade 2 or higher laboratory values and calculated creatinine clearance, creatinine, AST (SGOT), ALT (SGPT), ANC, hemoglobin, and platelet count regardless of grade; and any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. The Division of AIDS AE Grading Table, Version 2.0 was used.
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place