A Phase 2 interventional study of Ruxolitinib in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 2, Interventional, and Treatment
The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were virologically suppressed and who were on antiretroviral therapy (ART).
Ruxolitinib is a medication approved by the U.S. Food and Drug Administration (FDA) to treat myelofibrosis, a disorder in which bone marrow is replaced by scar (fibrosis) tissue. Many of the cytokines affected by myelofibrosis are also affected by HIV. Because of this, ruxolitinib may also be a possible treatment for HIV. The purpose of this study was to evaluate the safety and tolerability of ruxolitinib in HIV-positive adults who were on ART and who were virologically suppressed. Researchers evaluated the effect ruxolitinib had on inflammation and immune activation.
This study enrolled HIV-positive adults who were on select ART regimens and who had viral suppression. ART was not provided by the study; participants continued to receive ART from their own health care providers. Participants were randomly assigned to receive either ruxolitinib (Arm A) or no study treatment (Arm B) in 2:1 ratio. Participants in Arm A received ruxolitinib twice a day for 5 weeks. All participants attended study visits at entry (Day 0) and Weeks 1, 2, 4, 5, 10, and 12. These visits included physical examinations, clinical assessments, blood collection, adherence assessments, oral swab collection, and pregnancy testing for female participants. At Weeks 1 and 4, participants in Arm A took part in pharmacokinetic (PK) sampling, which involved having blood drawn several times over 6 to 8 hours.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 60 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
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The following laboratory values obtained within 45 days prior to entry:
Exclusion Criteria:
Any current diagnosis or past history of a significant cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, neuropsychiatric, psychiatric, or other serious illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data or affect the participant's ability to participate in the study. Diagnoses that would lead to exclusion include, but were not limited to the following:
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.
Drug: Ruxolitinib
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.
10 mg orally twice daily for 5 weeks
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Discontinuation of Ruxolitinib due to thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity related to study drug Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 5
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 5
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Events defined as safety milestones are listed below. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Time frame: Entry to Week 5
Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm
Number of participants with premature discontinuation of study treatment are summarized.
Time frame: Entry to Week 5
Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline.
Time frame: Pre-entry, Entry, Weeks 4 and 5
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Discontinuation of Ruxolitinib due to thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity related to study drug Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 12
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 12
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Events defined as safety milestones are listed below. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm3 (for participants with entry CD4+ T cell count \< 700 cells/mm3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Time frame: Entry to Week 12
Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.
Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual. This is a subset of the events reported in the Adverse Events section.
Time frame: Entry to Week 12
Creatinine Clearance
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Clearance Values From Entry
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Creatinine
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Creatinine Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Absolute Neutrophil Count (ANC)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Absolute Neutrophil Count (ANC) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Hemoglobin
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Hemoglobin Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Platelet Count
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Platelet Counts From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Aspartate Aminotransferase (AST) (SGOT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Alanine Aminotransferase (ALT) (SGPT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12.
Time frame: Pre-entry, Entry, Weeks 4, 5, 10 and 12
Fold Change in the Level of Soluble CD14 (sCD14)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Change in CD4+ T Cell Count
Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12.
Time frame: Pre-entry, Entry, Weeks 2, 5, and 12
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point.
Time frame: Entry, Weeks 2, 5, and 12
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA \<0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5).
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha)
Laboratory testing was not performed so the data are not available.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10)
Laboratory testing was not performed so the data are not available.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Macrophage Colony-stimulating Factor
Laboratory testing was not performed so the data are not available.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Neopterin
Data not available because the testing lab reported that the values were unreliable.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD38+HLADR+
Absolute change in the percent of parent cells (CD4+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD38+HLADR+
Absolute change in the percent of parent cells (CD8+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD25hi+
Absolute change in the percent of parent cells (CD4+) that express CD25hi+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD25+
Absolute change in the percent of parent cells (CD8+) that express CD25+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CD127+
Absolute change in the percent of parent cells (CD4+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CD127+
Absolute change in the percent of parent cells (CD8+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) Ki67+
Absolute change in the percent of parent cells (CD4+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) Ki67+
Absolute change in the percent of parent cells (CD8+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) Bcl2+
Absolute change in the percent of parent cells (CD4+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) Bcl2+
Absolute change in the percent of parent cells (CD8+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) a4b7+
Absolute change in the percent of parent cells (CD4+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) a4b7+
Absolute change in the percent of parent cells (CD8+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD4+) CX3CR1+
Absolute change in the percent of parent cells (CD4+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in (CD3+CD8+) CX3CR1+
Absolute change in the percent of parent cells (CD8+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in CD69
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69.
Time frame: Entry, Weeks 5 and 12
Change in PAR-1
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1.
Time frame: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CD163+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+
Absolute change in the percent of inflammatory monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in Cellular HIV-1 DNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Fold Change in Cellular HIV-1 Total RNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Percentage of Participants With Detectable CMV Shedding
Level of CMV shedding was summarized by study week and arm as the percentage of those above and below the assay limit of detection. Detectable CMV shedding was defined as CMV level \> 0 copies/ml of elution. The percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) was contrasted between study arms.
Time frame: Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12
Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK)
Ruxolitinib plasma concentrations were fitted to a population 2-compartment distribution model, assuming first-order input, distribution and elimination from the plasma compartment, using nonlinear mixed-effects modeling software. We estimated parameter geometric means and proportional variabilities between subjects (IIV when feasible) and the variability in drug absorption between occasions (IOV week 1 and week 4/5), and related distribution volumes to body weight.
Time frame: Week 1 and, Week 4/5; blood samples were drawn pre-dose and at 1-1.5, 2.5-4, 4-6, and 6-8 hours post-dosing
Change in 2 Long-terminal Repeat Sequences [LTRs]
Data not available because all values were below assay limit.
Time frame: Entry, Week 5, and Week 12
Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8)
Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant.
Time frame: Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12
Fold Change in Integrated DNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
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.
| Milestone | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Started | 40 | 20 |
| Completed | 40 | 19 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
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.
| percentage of participants | Arm A: Ruxolitinib |
|---|---|
| Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment | 2.5 |
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
| percentage of participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5 | 2.5 | 0 |
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.
| percentage of participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Confirmed CD4+ decline > 33% of entry | 0 | 0 |
| Confirmed CD4+ decline > 50% of entry | 0 | 0 |
| Confirmed HIV-1 RNA level above the lower limit | 0 | 0 |
| New/recurrent category C AIDS-indicator condition | 0 | 0 |
| HIV-1 associated infection including Herpes zoster | 0 | 0 |
| Lymphoproliferative malignancies | 0 | 0 |
| Grade 4/ recurrence of Grade 3 anemia/neutropenia | 0 | 0 |
| New diagnosis of pneumonia, sepsis, or bacteremia | 2.5 | 0 |
| Occurrence of Grade 2 or higher thrombocytopenia | 0 | 0 |
| Any Grade 4 or recurrence of Grade 3 toxicity | 0 | 0 |
Number of participants with premature discontinuation of study treatment are summarized.
| Participants | Arm A: Ruxolitinib |
|---|---|
| Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm | 3 |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5 | 0.93 (0.82 to 1.06) | 1.10 (0.84 to 1.44) |
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.
| percentage of participants | Arm A: Ruxolitinib |
|---|---|
| Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up | 7.5 |
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
| percentage of participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12 | 7.5 | 0 |
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.
| percentage of participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Confirmed CD4+ decline > 33% of entry | 0 | 0 |
| Confirmed CD4+ decline > 50% of entry | 2.5 | 0 |
| Confirmed HIV-1 RNA level above the lower limit | 2.5 | 0 |
| New/recurrent category C AIDS-indicator condition | 0 | 0 |
| HIV-1 associated infection including Herpes zoster | 0 | 0 |
| Lymphoproliferative malignancies | 0 | 0 |
| Grade 4/ recurrence of Grade 3 anemia/neutropenia | 0 | 0 |
| New diagnosis of pneumonia, sepsis, or bacteremia | 2.5 | 0 |
| Occurrence of Grade 2 or higher thrombocytopenia | 0 | 0 |
| Any Grade 4 or recurrence of Grade 3 toxicity | 0 | 0 |
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.
| Participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point. | 10 | 2 |
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.
| mL/min | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 118.5 (107.8 to 129.1) | 134.5 (115.4 to 153.6) |
| Week 1/2 | 116.3 (106.6 to 126.0) | 130.2 (110.3 to 150.1) |
| Week 4/5 | 117.3 (106.3 to 128.3) | 130.9 (111.5 to 150.4) |
| Week 10/12 | 117.8 (108.3 to 127.2) | 126.6 (107.4 to 145.9) |
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.
| mL/min | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | -2.16 (-5.97 to 1.65) | -3.47 (-9.34 to 2.40) |
| Change From Entry to Week 4/5 | -1.17 (-6.00 to 3.66) | -2.78 (-8.81 to 3.24) |
| Change From Entry to Week 10/12 | -0.71 (-5.07 to 3.65) | -7.06 (-13.1 to -1.04) |
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.
| mg/dL | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 0.99 (0.93 to 1.05) | 0.92 (0.85 to 0.99) |
| Week 1/2 | 1.0 (0.94 to 1.06) | 0.95 (0.87 to 1.03) |
| Week 4/5 | 1.01 (0.94 to 1.07) | 0.95 (0.87 to 1.02) |
| Week 10/12 | 0.99 (0.93 to 1.04) | 0.99 (0.91 to 1.06) |
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.
| mL/min | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | 0.01 (-0.02 to 0.05) | 0.03 (-0.01 to 0.07) |
| Change From Entry to Week 4/5 | 0.02 (-0.02 to 0.05) | 0.03 (-0.02 to 0.07) |
| Change From Entry to Week 10/12 | -0.00 (-0.04 to 0.03) | 0.07 (0.03 to 0.10) |
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.
| cells/mm^3 | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 3558 (3049 to 4068) | 2730 (2244 to 3216) |
| Week 1/2 | 3390 (2879 to 3901) | 3312 (2583 to 4041) |
| Week 4/5 | 3307 (2834 to 3780) | 3163 (2434 to 3891) |
| Week 10/12 | 3857 (3252 to 4462) | 3067 (2494 to 3639) |
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.
| cells/mm^3 | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | -169 (-476 to 138.9) | 510 (-11.6 to 1032) |
| Change From Entry to Week 4/5 | -251 (-506 to 3.70) | 400 (-233 to 1033) |
| Change From Entry to Week 10/12 | 299 (-29.7 to 627) | 265 (-280 to 810) |
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.
| g/dL | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 14.3 (13.8 to 14.8) | 14.3 (13.8 to 14.7) |
| Week 1/2 | 14.0 (13.6 to 14.4) | 14.1 (13.6 to 14.7) |
| Week 4/5 | 13.6 (13.2 to 14.1) | 14.2 (13.6 to 14.8) |
| Week 10/12 | 14.4 (13.7 to 15.0) | 14.2 (13.7 to 14.7) |
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.
| g/dL | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | -0.28 (-0.48 to -0.08) | -0.15 (-0.44 to 0.14) |
| Change From Entry to Week 4/5 | -0.65 (-0.88 to -0.42) | -0.10 (-0.39 to 0.20) |
| Change From Entry to Week 10/12 | -0.07 (-0.58 to 0.73) | -0.08 (-0.35 to 0.19) |
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.
| Platelets/mm^3 | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 238508 (222160 to 254855) | 261868 (237968 to 285769) |
| Week 1/2 | 281525 (261316 to 301734) | 264492 (233571 to 295413) |
| Week 4/5 | 270943 (252682 to 289203) | 264155 (235979 to 292332) |
| Week 10/12 | 247323 (230033 to 264612) | 261184 (231331 to 291038) |
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.
| Platelets/mm^3 | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | 43018 (30682 to 55353) | 5264 (-13341 to 23868) |
| Change From Entry to Week 4/5 | 32435 (19716 to 45154) | 4603 (-11880 to 21086) |
| Change From Entry to Week 10/12 | 8815 (301 to 17329) | 3439 (-13976 to 20853) |
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.
| U/L | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 23.2 (20.6 to 25.7) | 23.1 (19.2 to 26.9) |
| Week 1/2 | 28.2 (24.1 to 32.2) | 23.5 (18.1 to 28.9) |
| Week 4/5 | 29.1 (25.2 to 32.9) | 21.2 (18.5 to 23.9) |
| Week 10/12 | 24.7 (22.0 to 27.3) | 21.0 (18.2 to 23.8) |
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.
| U/L | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | 5.01 (2.17 to 7.86) | 0.05 (-4.35 to 4.45) |
| Change From Entry to Week 4/5 | 5.89 (3.16 to 8.61) | -2.26 (-5.32 to 0.79) |
| Change From Entry to Week 10/12 | 1.48 (-0.45 to 3.40) | -2.47 (-5.58 to 0.63) |
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.
| U/L | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 24.3 (21.0 to 27.6) | 26.9 (20.2 to 33.5) |
| Week 1/2 | 28.5 (24.5 to 32.6) | 26.5 (18.7 to 34.2) |
| Week 4/5 | 30.6 (24.9 to 36.2) | 22.4 (18.1 to 26.7) |
| Week 10/12 | 24.9 (21.7 to 28.2) | 23.2 (18.6 to 27.7) |
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.
| U/L | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change From Entry to Week 1/2 | 4.21 (1.62 to 6.81) | -0.68 (-3.30 to 1.94) |
| Change From Entry to Week 4/5 | 6.25 (1.61 to 10.9) | -4.74 (-9.45 to -0.03) |
| Change From Entry to Week 10/12 | 0.64 (-1.72 to 2.99) | -4.00 (-8.52 to 0.52) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Baseline to Week 10/12 | 1.16 (0.96 to 1.41) | 1.06 (0.82 to 1.36) |
| Fold Change from Week 4/5 to Week 10/12 | 1.26 (1.06 to 1.49) | 0.92 (0.76 to 1.11) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Baseline to Week 4/5 | 0.96 (0.90 to 1.02) | 1.08 (0.93 to 1.26) |
| Fold Change from Baseline to Week 12 | 1.02 (0.91 to 1.15) | 1.08 (0.93 to 1.25) |
| Fold Change from Week 4/5 to Week 12 | 1.08 (0.96 to 1.20) | 1.02 (0.86 to 1.21) |
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.
| cells/mm^3 | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Baseline to Week 2 | 131.2 (66.6 to 195.8) | -10.9 (-75.0 to 53.3) |
| Change from Baseline to Week 5 | 66.1 (0.87 to 131.2) | -8.19 (-64.1 to 47.7) |
| Change from Baseline to Week 12 | 3.27 (-76.4 to 82.9) | 42.2 (-45.6 to 130.0) |
| Change from Week 5 to Week 12 | -62.1 (-153 to 28.9) | 50.4 (-46.2 to 146.9) |
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.
| Participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Entry | 1 | 0 |
| Week 2 | 0 | 0 |
| Week 5 | 2 | 0 |
| Week 12 | 1 | 0 |
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).
| Relative Risk | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Relative risk of SCA<LOD at Wk 5 compared to Entry | 1.20 (0.84 to 1.72) | 1.22 (0.82 to 1.81) |
| Relative risk of SCA<LOD at Wk12 compared to Entry | 0.82 (0.44 to 1.53) | 1.11 (0.64 to 1.92) |
| Relative risk of SCA<LOD at Wk12 compared to Wk5 | 0.75 (0.43 to 1.32) | 0.91 (0.60 to 1.38) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.79 (0.71 to 0.88) | 0.90 (0.82 to 0.99) |
| Fold Change from Entry to Week 12 | 0.85 (0.63 to 1.14) | 0.92 (0.73 to 1.15) |
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.96 (0.72 to 1.27) | 0.75 (0.55 to 1.03) |
| Fold Change from Entry to Week 12 | 1.24 (0.60 to 2.60) | 0.78 (0.28 to 2.21) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 1.04 (0.82 to 1.33) | 0.81 (0.55 to 1.18) |
| Fold Change from Entry to Week 12 | 1.23 (0.92 to 1.65) | 1.04 (0.76 to 1.42) |
Laboratory testing was not performed so the data are not available.
No measurements were reported for this outcome.
Laboratory testing was not performed so the data are not available.
No measurements were reported for this outcome.
Laboratory testing was not performed so the data are not available.
No measurements were reported for this outcome.
Data not available because the testing lab reported that the values were unreliable.
No measurements were reported for this outcome.
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.94 (0.75 to 1.17) | 0.82 (0.47 to 1.43) |
| Fold Change from Entry to Week 12 | 0.65 (0.37 to 1.15) | 0.67 (0.39 to 1.16) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 1.33 (1.19 to 1.48) | 0.99 (0.87 to 1.13) |
| Fold Change from Entry to Week 12 | 1.06 (0.88 to 1.27) | 0.98 (0.87 to 1.11) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.89 (0.81 to 0.98) | 0.95 (0.84 to 1.07) |
| Fold Change from Entry to Week 12 | 1.05 (0.88 to 1.24) | 1.02 (0.90 to 1.15) |
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.90 (0.74 to 1.11) | 0.60 (0.44 to 0.83) |
| Fold Change from Entry to Week 12 | 1.91 (0.86 to 4.22) | 0.93 (0.71 to 1.24) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.96 (0.81 to 1.13) | 0.69 (0.52 to 0.90) |
| Fold Change from Entry to Week 12 | 0.90 (0.49 to 1.65) | 0.94 (0.62 to 1.41) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 0.99 (0.52 to 1.90) | 0.63 (0.23 to 1.69) |
| Fold Change from Entry to Week 12 | 0.67 (0.39 to 1.16) | 0.99 (0.42 to 2.36) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -0.27 (-0.47 to -0.07) | 0.08 (-0.18 to 0.33) |
| Change from Entry to Week 12 | 0.17 (0.01 to 0.32) | -0.10 (-0.38 to 0.18) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.16 (-1.67 to -0.65) | -0.28 (-1.09 to 0.53) |
| Change from Entry to Week 12 | 0.89 (0.16 to 1.62) | 0.03 (-0.94 to 1.00) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.50 (-1.95 to -1.05) | 0.22 (-0.74 to 1.18) |
| Change from Entry to Week 12 | 0.08 (-0.37 to 0.53) | -0.08 (-0.79 to 0.62) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -0.31 (-0.85 to 0.22) | -0.31 (-0.83 to 0.22) |
| Change from Entry to Week 12 | -0.53 (-1.25 to 0.19) | -0.38 (-1.23 to 0.48) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 2.65 (1.33 to 3.97) | -0.84 (-2.24 to 0.57) |
| Change from Entry to Week 12 | -1.48 (-2.94 to -0.03) | -0.19 (-1.97 to 1.60) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 5.42 (3.44 to 7.40) | -1.12 (-3.86 to 1.63) |
| Change from Entry to Week 12 | -0.09 (-2.53 to 2.35) | 0.11 (-3.05 to 3.26) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -0.26 (-0.55 to 0.02) | -0.19 (-0.95 to 0.58) |
| Change from Entry to Week 12 | 0.37 (0.00 to 0.73) | -0.39 (-1.11 to 0.32) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -0.64 (-0.88 to -0.41) | -0.65 (-1.50 to 0.19) |
| Change from Entry to Week 12 | 0.59 (-0.03 to 1.21) | 0.04 (-1.26 to 1.33) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -3.77 (-4.93 to -2.62) | -0.48 (-1.31 to 0.35) |
| Change from Entry to Week 12 | -0.67 (-1.11 to -0.23) | 0.06 (-0.81 to 0.92) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -5.64 (-7.19 to -4.09) | -0.24 (-1.20 to 0.72) |
| Change from Entry to Week 12 | -1.29 (-2.14 to -0.44) | -0.06 (-1.50 to 1.38) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -2.16 (-3.43 to -0.88) | -0.62 (-3.64 to 2.40) |
| Change from Entry to Week 12 | -0.01 (-1.45 to 1.43) | 0.38 (-1.58 to 2.34) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 0.01 (-1.62 to 1.65) | -0.54 (-3.30 to 2.22) |
| Change from Entry to Week 12 | 0.91 (-0.80 to 2.61) | 0.59 (-1.99 to 3.18) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.55 (-2.14 to -0.96) | -0.22 (-1.00 to 0.56) |
| Change from Entry to Week 12 | -0.21 (-0.66 to 0.24) | -0.04 (-1.26 to 1.19) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -4.31 (-5.46 to -3.16) | -1.07 (-3.71 to 1.57) |
| Change from Entry to Week 12 | -0.39 (-1.79 to 1.02) | -0.22 (-2.87 to 2.43) |
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69.
No measurements were reported for this outcome.
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1.
No measurements were reported for this outcome.
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 0.95 (-1.49 to 3.40) | -0.43 (-2.66 to 1.80) |
| Change from Entry to Week 12 | 1.15 (-0.85 to 3.15) | -1.06 (-4.27 to 2.15) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.16 (-5.47 to 3.15) | 3.18 (-4.62 to 11.0) |
| Change from Entry to Week 12 | -5.05 (-9.68 to -0.43) | 4.76 (-2.36 to 11.9) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.24 (-2.83 to 0.35) | -0.43 (-2.44 to 1.58) |
| Change from Entry to Week 12 | -0.84 (-1.77 to 0.09) | 0.86 (-1.43 to 3.15) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.72 (-2.99 to -0.44) | -0.25 (-1.52 to 1.02) |
| Change from Entry to Week 12 | -0.62 (-2.89 to 1.65) | 1.00 (-0.96 to 2.96) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -1.21 (-2.46 to 0.03) | -0.36 (-1.57 to 0.86) |
| Change from Entry to Week 12 | -0.49 (-1.85 to 0.88) | 0.22 (-1.44 to 1.88) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -3.88 (-8.29 to 0.53) | 2.14 (-2.62 to 6.89) |
| Change from Entry to Week 12 | -4.40 (-7.97 to -0.82) | 2.00 (-1.00 to 4.99) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 2.95 (-1.81 to 7.71) | 2.67 (-6.40 to 11.7) |
| Change from Entry to Week 12 | -1.99 (-7.17 to 3.20) | 2.11 (-8.76 to 13.0) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -4.38 (-8.56 to -0.20) | -5.61 (-12.6 to 1.40) |
| Change from Entry to Week 12 | 0.58 (-5.47 to 6.63) | -3.18 (-7.12 to 0.76) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 0.20 (-1.56 to 1.96) | 0.83 (-0.98 to 2.65) |
| Change from Entry to Week 12 | -0.70 (-2.28 to 0.89) | 0.87 (-1.69 to 3.42) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -4.05 (-7.55 to -0.54) | 3.05 (-0.27 to 6.37) |
| Change from Entry to Week 12 | -1.09 (-5.90 to 3.73) | 0.41 (-5.06 to 5.88) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | 0.02 (-0.03 to 0.07) | 0.01 (-0.03 to 0.06) |
| Change from Entry to Week 12 | 0.04 (-0.01 to 0.10) | 0.04 (-0.03 to 0.10) |
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.
| Percent of Expression in Parent Cell | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Change from Entry to Week 5 | -5.48 (-9.38 to -1.59) | -2.64 (-9.44 to 4.17) |
| Change from Entry to Week 12 | -2.39 (-7.64 to 2.87) | -2.42 (-4.73 to -0.10) |
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 1.16 (0.96 to 1.41) | 0.62 (0.36 to 1.06) |
| Fold Change from Entry to Week 12 | 1.18 (0.98 to 1.42) | 0.90 (0.52 to 1.55) |
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 1.06 (0.82 to 1.38) | 0.87 (0.66 to 1.15) |
| Fold Change from Entry to Week 12 | 0.97 (0.74 to 1.29) | 0.95 (0.60 to 1.50) |
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.
| percentage of participants | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Pre-entry | 13 | 5 |
| Entry | 13 | 10 |
| Week 1 | 13 | 11 |
| Week 2 | 8 | 16 |
| Week 4 | 8 | 6 |
| Week 5 | 5 | 16 |
| Week 10 | 5 | 11 |
| Week 12 | 20 | 16 |
| Any Detectable CMV On-treatment | 18 | 26 |
| Any Detectable CMV Post-treatment | 20 | 16 |
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.
| L/hr | Arm A: Ruxolitinib |
|---|---|
| Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK) | 14.5 ± 34 |
Data not available because all values were below assay limit.
No measurements were reported for this outcome.
Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant.
No measurements were reported for this outcome.
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.
| Fold Change | Arm A: Ruxolitinib | Arm B: No Study Treatment |
|---|---|---|
| Fold Change from Entry to Week 5 | 1.10 (0.44 to 2.71) | 2.06 (0.61 to 6.98) |
| Fold Change from Entry to Week 12 | 1.11 (0.31 to 4.00) | 1.20 (0.43 to 3.36) |
Collected over Week 0 to Week 12. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ruxolitinib | 0/40 (0%) | 2/40 (5%) | 31/40 (77.5%) |
| No Study Treatment | 0/20 (0%) | 0/20 (0%) | 15/20 (75%) |
| Event | Ruxolitinib | No Study Treatment |
|---|---|---|
| Vitreous detachmentEye disorders | 1/40 | 0/20 |
| MalnutritionMetabolism and nutrition disorders | 1/40 | 0/20 |
| Event | Ruxolitinib | No Study Treatment |
|---|---|---|
| Low density lipoprotein increasedInvestigations | 7/40 | 8/20 |
| Blood cholesterol increasedInvestigations | 9/40 | 7/20 |
| Blood triglycerides increasedInvestigations | 13/40 | 6/20 |
| Aspartate aminotransferase increasedInvestigations | 8/40 | 2/20 |
| Blood glucose increasedInvestigations | 7/40 | 3/20 |
| Alanine aminotransferase increasedInvestigations | 5/40 | 2/20 |
| Blood creatinine increasedInvestigations | 5/40 | 2/20 |
| Abdominal pain lowerGastrointestinal disorders | 0/40 | 1/20 |
| Lip swellingGastrointestinal disorders | 0/40 | 1/20 |
| FatigueGeneral disorders | 2/40 | 0/20 |
All enrolled participants.
| Age, Continuous(years) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Median | 49 (45 to 54) | 43.5 (31 to 54) | 49 (36.5 to 54) |
| Sex: Female, Male(Participants) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Female | 8 | 4 | 12 |
| Male | 32 | 16 | 48 |
| Race/Ethnicity, Customized(Participants) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Race/Ethnicity — White Non-Hispanic | 14 | 7 | 21 |
| Race/Ethnicity — Black Non-Hispanic | 19 | 10 | 29 |
| Race/Ethnicity — Hispanic (Regardless of Race) | 4 | 2 | 6 |
| Race/Ethnicity — More than One Race | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| United States | 40 | 20 | 60 |
| Weight(kg) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Median | 89.2 (77.7 to 110.1) | 91.0 (76.1 to 104.5) | 89.2 (76.7 to 108.8) |
| BMI(kg/m^2) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Median | 29.2 (25.0 to 33.5) | 29.5 (26.8 to 35.4) | 29.2 (25.6 to 34.3) |
| Entry CD4 Count(cells/mm^3) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Median | 798 (628 to 973) | 737 (610 to 930) | 791 (622 to 972) |
| Baseline CD4 Count(cells/mm^3) | Arm A: Ruxolitinib | Arm B: No Study Treatment | Total |
|---|---|---|---|
| Median | 816 (639 to 958) | 855 (629 to 948) | 844 (639 to 948) |
2 further baseline measures are reported on the registry.
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National Institute of Allergy and Infectious Diseases (NIAID)