HIV Infections
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGRuxolitinib
10 mg orally twice daily for 5 weeks
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* HIV-1 infection * CD4+ T cell count greater than 350 cells/mm\^3 within 45 days prior to study entry * Documented virologic suppression defined as HIV-1 RNA level below the limit of quantification (eg, less than 40, less than 50, or less than 75 copies/mL, depending on the assay) using an FDA-approved assay with a quantification limit of 75 copies/mL or lower for at least 48 weeks prior to study entry * Screening HIV-1 RNA level below the limit of quantification * Tuberculosis (TB) screening within 365 days of the screening visit diagnosed by tuberculin skin test or interferon gamma release assay * Currently on continuous ART for at least 730 days prior to study entry, defined as continuous ART for the 730 days period, inclusive, prior to study entry with no ART interruption longer than 7 consecutive days. NOTE: The current regimen must include TDF/FTC, TAF/FTC, TDF+3TC, or ABC/3TC; plus a nonnucleoside reverse transcriptase inhibitor or integrase strand transfer inhibitor (NNRTI or INSTI, not containing cobicistat) for at least 60 days, inclusive, prior to study entry. * The following laboratory values obtained within 45 days prior to entry: * Absolute neutrophil count (ANC) greater than or equal to 1,000/mm\^3 * Hemoglobin greater than 12.0 g/dL for men and greater than 11.0 g/dL for women * Platelets greater than or equal to 140,000/mm\^3 * Calculated creatinine clearance (CrCl) greater than or equal to 70 mL/min (by Cockcroft Gault equation) * Aspartate aminotransferase (AST) (SGOT) less than or equal to 1.5x upper limit of normal (ULN) * Alanine aminotransferase (ALT) (SGPT) less than or equal to 1.5x ULN * Alkaline phosphatase less than or equal to 1.5x ULN * For females of reproductive potential, a negative serum or urine pregnancy test with a sensitivity of 25 mIU/mL within 72 hours, inclusive, prior to study entry * All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) * All participants of reproductive potential, who were participating in sexual activity that could lead to pregnancy, must agree to use at least one reliable method of contraception while receiving the study drugs and for 7 weeks after stopping the medications * Ability and willingness of participant or legal representative to provide written informed consent and attend study visits as scheduled at a participating site
Exclusion criteria
* A current or past history of progressive multifocal leukoencephalopathy * Breastfeeding or pregnancy * Use of strong inhibitors or inducers of CYP3A4 including a protease inhibitor, cobicistat or entry inhibitors as part of the current ART regimen or other concomitant therapy * Known allergy/sensitivity or any hypersensitivity to components of study drug or their formulation * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Acute or serious illness or infection requiring systemic treatment and/or hospitalization within 60 days prior to entry * Vaccinations (other than influenza) less than or equal to 45 days prior to the study entry visit. * Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy or investigational therapy less than or equal to 60 days prior to study entry * 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: * CDC category C AIDS-indicator conditions * NOTE A: Except HIV encephalopathy, HIV wasting, esophageal candidiasis, or pneumocystis pneumonia without dissemination. * NOTE B: List available: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm * Herpes zoster (dermatomal or non-dermatomal). * NOTE C: A history of prior chickenpox was not exclusionary. * Lymphoproliferative malignancy * Chronic liver disease of any etiology and any degree of severity * Chronic hepatitis, except for hepatitis C that has been cured (defined as a Sustained Virologic Response, which is an undetectable HCV-RNA at 12 weeks or more after completing treatment measured by a sensitive, qualitative, or quantitative HCV-RNA assay) * Disseminated fungal infection of any type or duration that is not limited to cutaneous or mucocutaneous surfaces * A medical disorder that predisposes to bleeding * Change in the ART regimen within 12 weeks, inclusive, prior to study entry or intended modification of ART during the study. * History of untreated latent tuberculosis infection (LTBI) diagnosed by tuberculin skin test or interferon gamma release assay. LTBI treatment would consist of 9 months of isoniazid or an equivalent therapy completed at least 4 weeks prior to study entry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5 | Pre-entry, Entry, Weeks 4 and 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. |
| Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5 | 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. |
| Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm | Entry to Week 5 | Number of participants with premature discontinuation of study treatment are summarized. |
| Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment | 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 * 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 Who Experienced Any Safety Milestones On-study From Entry to Week 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point. | Entry to Week 12 | 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. |
| Creatinine Clearance | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Creatinine Clearance Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Creatinine Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Absolute Neutrophil Count (ANC) | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Absolute Neutrophil Count (ANC) Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Hemoglobin | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Hemoglobin Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Platelet Count | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Platelet Counts From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Aspartate Aminotransferase (AST) (SGOT) | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Alanine Aminotransferase (ALT) (SGPT) | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Fold Change in the Level of Plasma Interleukin 6 (IL-6) | Pre-entry, Entry, Weeks 4, 5, 10 and 12 | 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 in the Level of Soluble CD14 (sCD14) | Pre-entry, Entry, Weeks 4, 5, and 12 | 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. |
| Change in CD4+ T Cell Count | Pre-entry, Entry, Weeks 2, 5, and 12 | 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. |
| Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Entry, Weeks 2, 5, and 12 | 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. |
| Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL | Entry, Weeks 5 and 12 | 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). |
| Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Interleukin 7 (IL-7) | Entry, Weeks 5 and 12 | 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 in the Level of Interleukin 1 Alpha (IL-1 Alpha) | Pre-entry, Entry, Weeks 4, 5, and 12 | Laboratory testing was not performed so the data are not available. |
| Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10) | Pre-entry, Entry, Weeks 4, 5, and 12 | Laboratory testing was not performed so the data are not available. |
| Fold Change in the Level of Macrophage Colony-stimulating Factor | Pre-entry, Entry, Weeks 4, 5, and 12 | Laboratory testing was not performed so the data are not available. |
| Fold Change in the Level of Neopterin | Pre-entry, Entry, Weeks 4, 5, and 12 | Data not available because the testing lab reported that the values were unreliable. |
| Fold Change in the Level of Plasma Interleukin 10 (IL-10) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Interleukin 15 (IL-15) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Interleukin 18 (IL-18) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2) | Entry, Weeks 5 and 12 | 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 in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3) | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) CD38+HLADR+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) CD38+HLADR+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) CD25hi+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) CD25+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) CD127+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) CD127+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) Ki67+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) Ki67+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) Bcl2+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) Bcl2+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) a4b7+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) a4b7+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD4+) CX3CR1+ | Entry, Weeks 5 and 12 | 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. |
| Change in (CD3+CD8+) CX3CR1+ | Entry, Weeks 5 and 12 | 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. |
| Change in CD69 | Entry, Weeks 5 and 12 | Data not available because the team decided they were no longer clinically relevant, so samples were not tested for CD69. |
| Change in PAR-1 | Entry, Weeks 5 and 12 | Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1. |
| Change in Classical Monocytes (CD14+CD16-) | Entry, Weeks 5 and 12 | 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. |
| Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Entry, Weeks 5 and 12 | 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. |
| Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Entry, Weeks 5 and 12 | 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. |
| Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Entry, Weeks 5 and 12 | 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. |
| Change in Inflammatory Monocytes (CD14+CD16+) | Entry, Weeks 5 and 12 | 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. |
| Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Entry, Weeks 5 and 12 | 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. |
| Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Entry, Weeks 5 and 12 | 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. |
| Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Entry, Weeks 5 and 12 | 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. |
| Change in Patrolling Monocytes (CD14dimCD16+) | Entry, Weeks 5 and 12 | 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. |
| Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Entry, Weeks 5 and 12 | 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. |
| Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Entry, Weeks 5 and 12 | 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. |
| Fold Change in Cellular HIV-1 DNA | Entry, Weeks 5 and 12 | 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 in Cellular HIV-1 Total RNA | Entry, Weeks 5 and 12 | 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. |
| Percentage of Participants With Detectable CMV Shedding | Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK) | 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 | 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. |
| Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Entry, Weeks 5 and 12 | 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. |
| Creatinine | Entry, Weeks 1, 2, 4, 5, 10, and 12 | 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. |
| Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up | 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 * 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 Who Experienced Any Safety Milestones On-study From Entry to Week 12 | 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. |
| Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in 2 Long-terminal Repeat Sequences [LTRs] | Entry, Week 5, and Week 12 | Data not available because all values were below assay limit. |
| Fold Change in Integrated DNA | Entry, Weeks 5 and 12 | 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. |
| Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8) | Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12 | Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Enrollment was stratified based on whether a participant was on an EFV-containing regimen.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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. | 20 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Arm A: Ruxolitinib | Total | Arm B: No Study Treatment |
|---|---|---|---|
| Age, Continuous | 49 years | 49 years | 43.5 years |
| Baseline CD4 Count | 816 cells/mm^3 | 844 cells/mm^3 | 855 cells/mm^3 |
| Baseline Interleukin 6 (IL-6) | 1.90 pg/mL STANDARD_DEVIATION 1.84 | 1.83 pg/mL STANDARD_DEVIATION 1.79 | 1.69 pg/mL STANDARD_DEVIATION 1.68 |
| BMI | 29.2 kg/m^2 | 29.2 kg/m^2 | 29.5 kg/m^2 |
| Entry CD4 Count | 798 cells/mm^3 | 791 cells/mm^3 | 737 cells/mm^3 |
| HIV-1 RNA <40 copies/mL | 39 Participants | 59 Participants | 20 Participants |
| HIV-1 RNA >=40 copies/mL | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black Non-Hispanic | 19 Participants | 29 Participants | 10 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic (Regardless of Race) | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity More than One Race | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Non-Hispanic | 14 Participants | 21 Participants | 7 Participants |
| Region of Enrollment United States | 40 Participants | 60 Participants | 20 Participants |
| Sex: Female, Male Female | 8 Participants | 12 Participants | 4 Participants |
| Sex: Female, Male Male | 32 Participants | 48 Participants | 16 Participants |
| Weight | 89.2 kg | 89.2 kg | 91.0 kg |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 |
| other Total, other adverse events | 31 / 40 | 15 / 20 |
| serious Total, serious adverse events | 2 / 40 | 0 / 20 |
Outcome results
Primary
Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline.
Time frame: Pre-entry, Entry, Weeks 4 and 5
Population: 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).
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5 | 0.93 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 6 (IL-6) From Baseline to Week 4/5 | 1.10 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to week 4/5.p-value: 0.1890% CI: [0.69, 1.04]t-test, 2 sided
Primary
Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm
Number of participants with premature discontinuation of study treatment are summarized.
Time frame: Entry to Week 5
Population: All participants on the Ruxolitinib arm are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Ruxolitinib | Number of Participants With Premature Discontinuation of Study Treatment in the Ruxolitinib Arm | 3 Participants |
Primary
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Discontinuation of Ruxolitinib due to thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity related to study drug Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 5
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ruxolitinib | Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events While On-Treatment | 2.5 percentage of participants |
Primary
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 5
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ruxolitinib | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5 | 2.5 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 5 | 0 percentage of participants |
Comparison: Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 5.p-value: 0.67Fisher Exact
Primary
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5
Events defined as safety milestones are listed below. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Time frame: Entry to Week 5
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5 | Lymphoproliferative malignancies | 0 percentage of participants |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5 | New diagnosis of pneumonia, sepsis, or bacteremia | 0 percentage of participants |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 5 | Lymphoproliferative malignancies | 0 percentage of participants |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
Secondary
Absolute Neutrophil Count (ANC)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Absolute Neutrophil Count (ANC) | Entry | 3558 cells/mm^3 |
| Arm A: Ruxolitinib | Absolute Neutrophil Count (ANC) | Week 1/2 | 3390 cells/mm^3 |
| Arm A: Ruxolitinib | Absolute Neutrophil Count (ANC) | Week 4/5 | 3307 cells/mm^3 |
| Arm A: Ruxolitinib | Absolute Neutrophil Count (ANC) | Week 10/12 | 3857 cells/mm^3 |
| Arm B: No Study Treatment | Absolute Neutrophil Count (ANC) | Week 10/12 | 3067 cells/mm^3 |
| Arm B: No Study Treatment | Absolute Neutrophil Count (ANC) | Entry | 2730 cells/mm^3 |
| Arm B: No Study Treatment | Absolute Neutrophil Count (ANC) | Week 4/5 | 3163 cells/mm^3 |
| Arm B: No Study Treatment | Absolute Neutrophil Count (ANC) | Week 1/2 | 3312 cells/mm^3 |
Secondary
Alanine Aminotransferase (ALT) (SGPT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Alanine Aminotransferase (ALT) (SGPT) | Week 10/12 | 24.9 U/L |
| Arm A: Ruxolitinib | Alanine Aminotransferase (ALT) (SGPT) | Week 1/2 | 28.5 U/L |
| Arm A: Ruxolitinib | Alanine Aminotransferase (ALT) (SGPT) | Week 4/5 | 30.6 U/L |
| Arm A: Ruxolitinib | Alanine Aminotransferase (ALT) (SGPT) | Entry | 24.3 U/L |
| Arm B: No Study Treatment | Alanine Aminotransferase (ALT) (SGPT) | Week 4/5 | 22.4 U/L |
| Arm B: No Study Treatment | Alanine Aminotransferase (ALT) (SGPT) | Entry | 26.9 U/L |
| Arm B: No Study Treatment | Alanine Aminotransferase (ALT) (SGPT) | Week 10/12 | 23.2 U/L |
| Arm B: No Study Treatment | Alanine Aminotransferase (ALT) (SGPT) | Week 1/2 | 26.5 U/L |
Secondary
Aspartate Aminotransferase (AST) (SGOT)
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Aspartate Aminotransferase (AST) (SGOT) | Entry | 23.2 U/L |
| Arm A: Ruxolitinib | Aspartate Aminotransferase (AST) (SGOT) | Week 1/2 | 28.2 U/L |
| Arm A: Ruxolitinib | Aspartate Aminotransferase (AST) (SGOT) | Week 4/5 | 29.1 U/L |
| Arm A: Ruxolitinib | Aspartate Aminotransferase (AST) (SGOT) | Week 10/12 | 24.7 U/L |
| Arm B: No Study Treatment | Aspartate Aminotransferase (AST) (SGOT) | Week 10/12 | 21.0 U/L |
| Arm B: No Study Treatment | Aspartate Aminotransferase (AST) (SGOT) | Entry | 23.1 U/L |
| Arm B: No Study Treatment | Aspartate Aminotransferase (AST) (SGOT) | Week 4/5 | 21.2 U/L |
| Arm B: No Study Treatment | Aspartate Aminotransferase (AST) (SGOT) | Week 1/2 | 23.5 U/L |
Secondary
Change in Absolute Neutrophil Count (ANC) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 1/2 | -169 cells/mm^3 |
| Arm A: Ruxolitinib | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 4/5 | -251 cells/mm^3 |
| Arm A: Ruxolitinib | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 10/12 | 299 cells/mm^3 |
| Arm B: No Study Treatment | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 1/2 | 510 cells/mm^3 |
| Arm B: No Study Treatment | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 4/5 | 400 cells/mm^3 |
| Arm B: No Study Treatment | Change in Absolute Neutrophil Count (ANC) Values From Entry | Change From Entry to Week 10/12 | 265 cells/mm^3 |
Comparison: Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 1/2.p-value: 0.01890% CI: [-1146, -212]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 4/5.p-value: 0.02190% CI: [-1110, -192]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in absolute neutrophil count (ANC) from Entry to Week 10/12.p-value: 0.9190% CI: [-461, 528]t-test, 2 sided
Secondary
Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 1/2 | 4.21 U/L |
| Arm A: Ruxolitinib | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 4/5 | 6.25 U/L |
| Arm A: Ruxolitinib | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 10/12 | 0.64 U/L |
| Arm B: No Study Treatment | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 1/2 | -0.68 U/L |
| Arm B: No Study Treatment | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 4/5 | -4.74 U/L |
| Arm B: No Study Treatment | Change in Alanine Aminotransferase (ALT) (SGPT) Values From Entry | Change From Entry to Week 10/12 | -4.00 U/L |
Comparison: Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 1/2.p-value: 0.0290% CI: [1.46, 8.33]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 4/5.p-value: 0.00490% CI: [4.84, 17.1]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in Alanine Aminotransferase (ALT) (SGPT) values from Entry to Week 10/12.p-value: 0.04390% CI: [0.88, 8.39]t-test, 2 sided
Secondary
Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 1/2 | 5.01 U/L |
| Arm A: Ruxolitinib | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 4/5 | 5.89 U/L |
| Arm A: Ruxolitinib | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 10/12 | 1.48 U/L |
| Arm B: No Study Treatment | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 1/2 | 0.05 U/L |
| Arm B: No Study Treatment | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 4/5 | -2.26 U/L |
| Arm B: No Study Treatment | Change in Aspartate Aminotransferase (AST) (SGOT) Values From Entry | Change From Entry to Week 10/12 | -2.47 U/L |
Comparison: Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 1/2.p-value: 0.0590% CI: [0.78, 9.14]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 4/5.p-value: <0.00190% CI: [4.47, 11.8]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in Aspartate Aminotransferase (AST) (SGOT) values from Entry to Week 10/12.p-value: 0.02590% CI: [1.08, 6.81]t-test, 2 sided
Secondary
Change in (CD3+CD4+) a4b7+
Absolute change in the percent of parent cells (CD4+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) a4b7+ | Change from Entry to Week 5 | -2.16 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) a4b7+ | Change from Entry to Week 12 | -0.01 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) a4b7+ | Change from Entry to Week 5 | -0.62 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) a4b7+ | Change from Entry to Week 12 | 0.38 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 5.p-value: 0.2690% CI: [-3.78, 0.7]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD4+ T-cells from Entry to Week 12.p-value: 0.7490% CI: [-2.41, 1.62]t-test, 2 sided
Secondary
Change in (CD3+CD4+) Bcl2+
Absolute change in the percent of parent cells (CD4+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) Bcl2+ | Change from Entry to Week 5 | -3.77 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) Bcl2+ | Change from Entry to Week 12 | -0.67 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) Bcl2+ | Change from Entry to Week 5 | -0.48 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) Bcl2+ | Change from Entry to Week 12 | 0.06 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 5.p-value: <0.00190% CI: [-4.72, -1.87]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD4+ T-cells from Entry to Week 12.p-value: 0.0990% CI: [-1.42, -0.03]t-test, 2 sided
Secondary
Change in (CD3+CD4+) CD127+
Absolute change in the percent of parent cells (CD4+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD127+ | Change from Entry to Week 5 | 2.65 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD127+ | Change from Entry to Week 12 | -1.48 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD127+ | Change from Entry to Week 5 | -0.84 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD127+ | Change from Entry to Week 12 | -0.19 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 5.p-value: 0.00190% CI: [1.75, 5.22]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD4+ T-cells from Entry to Week 12.p-value: 0.2890% CI: [-3.28, 0.68]t-test, 2 sided
Secondary
Change in (CD3+CD4+) CD25hi+
Absolute change in the percent of parent cells (CD4+) that express CD25hi+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD25hi+ | Change from Entry to Week 5 | -1.50 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD25hi+ | Change from Entry to Week 12 | 0.08 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD25hi+ | Change from Entry to Week 5 | 0.22 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD25hi+ | Change from Entry to Week 12 | -0.08 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 5.p-value: <0.00190% CI: [-2.46, -0.97]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD25hi+ among CD4+ T-cells from Entry to Week 12.p-value: 0.6890% CI: [-0.5, 0.82]t-test, 2 sided
Secondary
Change in (CD3+CD4+) CD38+HLADR+
Absolute change in the percent of parent cells (CD4+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD38+HLADR+ | Change from Entry to Week 5 | -0.27 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CD38+HLADR+ | Change from Entry to Week 12 | 0.17 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD38+HLADR+ | Change from Entry to Week 5 | 0.08 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CD38+HLADR+ | Change from Entry to Week 12 | -0.10 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 5.p-value: 0.03890% CI: [-0.61, -0.07]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD4+ T-cells from Entry to Week 12.p-value: 0.0790% CI: [0.03, 0.51]t-test, 2 sided
Secondary
Change in (CD3+CD4+) CX3CR1+
Absolute change in the percent of parent cells (CD4+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CX3CR1+ | Change from Entry to Week 5 | -1.55 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) CX3CR1+ | Change from Entry to Week 12 | -0.21 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CX3CR1+ | Change from Entry to Week 5 | -0.22 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) CX3CR1+ | Change from Entry to Week 12 | -0.04 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 5.p-value: 0.0190% CI: [-2.16, -0.5]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CX3CR1+ among CD4+ T-cells from Entry to Week 12.p-value: 0.7490% CI: [-1.02, 0.68]t-test, 2 sided
Secondary
Change in (CD3+CD4+) Ki67+
Absolute change in the percent of parent cells (CD4+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD4+) Ki67+ | Change from Entry to Week 5 | -0.26 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD4+) Ki67+ | Change from Entry to Week 12 | 0.37 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) Ki67+ | Change from Entry to Week 5 | -0.19 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD4+) Ki67+ | Change from Entry to Week 12 | -0.39 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 5.p-value: 0.8290% CI: [-0.61, 0.47]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD4+ T-cells from Entry to Week 12.p-value: 0.03390% CI: [0.18, 1.34]t-test, 2 sided
Secondary
Change in (CD3+CD8+) a4b7+
Absolute change in the percent of parent cells (CD8+) that express a4b7+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) a4b7+ | Change from Entry to Week 5 | 0.01 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) a4b7+ | Change from Entry to Week 12 | 0.91 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) a4b7+ | Change from Entry to Week 5 | -0.54 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) a4b7+ | Change from Entry to Week 12 | 0.59 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 5.p-value: 0.7190% CI: [-1.9, 3]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of a4b7+ among CD8+ T-cells from Entry to Week 12.p-value: 0.8390% CI: [-2.15, 2.78]t-test, 2 sided
Secondary
Change in (CD3+CD8+) Bcl2+
Absolute change in the percent of parent cells (CD8+) that express Bcl2+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) Bcl2+ | Change from Entry to Week 5 | -5.64 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) Bcl2+ | Change from Entry to Week 12 | -1.29 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) Bcl2+ | Change from Entry to Week 5 | -0.24 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) Bcl2+ | Change from Entry to Week 12 | -0.06 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 5.p-value: <0.00190% CI: [-7.29, -3.5]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Bcl2+ among CD8+ T-cells from Entry to Week 12.p-value: 0.1190% CI: [-2.51, 0.05]t-test, 2 sided
Secondary
Change in (CD3+CD8+) CD127+
Absolute change in the percent of parent cells (CD8+) that express CD127+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD127+ | Change from Entry to Week 5 | 5.42 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD127+ | Change from Entry to Week 12 | -0.09 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD127+ | Change from Entry to Week 5 | -1.12 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD127+ | Change from Entry to Week 12 | 0.11 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 5.p-value: <0.00190% CI: [3.76, 9.31]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD127+ among CD8+ T-cells from Entry to Week 12.p-value: 0.9290% CI: [-3.56, 3.18]t-test, 2 sided
Secondary
Change in (CD3+CD8+) CD25+
Absolute change in the percent of parent cells (CD8+) that express CD25+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD25+ | Change from Entry to Week 5 | -0.31 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD25+ | Change from Entry to Week 12 | -0.53 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD25+ | Change from Entry to Week 5 | -0.31 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD25+ | Change from Entry to Week 12 | -0.38 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 5.p-value: 0.9890% CI: [-0.7, 0.69]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD25+ among CD8+ T-cells from Entry to Week 12.p-value: 0.7990% CI: [-1.13, 0.82]t-test, 2 sided
Secondary
Change in (CD3+CD8+) CD38+HLADR+
Absolute change in the percent of parent cells (CD8+) that express CD38+HLADR+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD38+HLADR+ | Change from Entry to Week 5 | -1.16 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CD38+HLADR+ | Change from Entry to Week 12 | 0.89 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD38+HLADR+ | Change from Entry to Week 5 | -0.28 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CD38+HLADR+ | Change from Entry to Week 12 | 0.03 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.p-value: 0.0590% CI: [-1.62, -0.13]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.p-value: 0.1690% CI: [-0.16, 1.88]t-test, 2 sided
Secondary
Change in (CD3+CD8+) CX3CR1+
Absolute change in the percent of parent cells (CD8+) that express CX3CR1+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CX3CR1+ | Change from Entry to Week 5 | -4.31 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) CX3CR1+ | Change from Entry to Week 12 | -0.39 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CX3CR1+ | Change from Entry to Week 5 | -1.07 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) CX3CR1+ | Change from Entry to Week 12 | -0.22 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 5.p-value: 0.00890% CI: [-5.22, -1.27]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of CD38+HLADR+ among CD8+ T-cells from Entry to Week 12.p-value: 0.990% CI: [-2.38, 2.05]t-test, 2 sided
Secondary
Change in (CD3+CD8+) Ki67+
Absolute change in the percent of parent cells (CD8+) that express Ki67+ cells (cellular marker of immune activation and inflammation in the peripheral blood). Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in (CD3+CD8+) Ki67+ | Change from Entry to Week 5 | -0.64 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in (CD3+CD8+) Ki67+ | Change from Entry to Week 12 | 0.59 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) Ki67+ | Change from Entry to Week 5 | -0.65 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in (CD3+CD8+) Ki67+ | Change from Entry to Week 12 | 0.04 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 5.p-value: 0.9890% CI: [-0.53, 0.55]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in the expression of Ki67+ among CD8+ T-cells from Entry to Week 12.p-value: 0.3790% CI: [-0.46, 1.57]t-test, 2 sided
Secondary
Change in CD4+ T Cell Count
Baseline is defined as the average of pre-entry and entry. Absolute change was calculated as the value at Week 2 minus the value at Baseline, the value at week 5 minus the value at baseline, the value at week 12 minus the value at baseline, and the value at week 5 minus the value at week 12.
Time frame: Pre-entry, Entry, Weeks 2, 5, and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in CD4+ T Cell Count | Change from Baseline to Week 2 | 131.2 cells/mm^3 |
| Arm A: Ruxolitinib | Change in CD4+ T Cell Count | Change from Baseline to Week 5 | 66.1 cells/mm^3 |
| Arm A: Ruxolitinib | Change in CD4+ T Cell Count | Change from Baseline to Week 12 | 3.27 cells/mm^3 |
| Arm A: Ruxolitinib | Change in CD4+ T Cell Count | Change from Week 5 to Week 12 | -62.1 cells/mm^3 |
| Arm B: No Study Treatment | Change in CD4+ T Cell Count | Change from Week 5 to Week 12 | 50.4 cells/mm^3 |
| Arm B: No Study Treatment | Change in CD4+ T Cell Count | Change from Baseline to Week 2 | -10.9 cells/mm^3 |
| Arm B: No Study Treatment | Change in CD4+ T Cell Count | Change from Baseline to Week 12 | 42.2 cells/mm^3 |
| Arm B: No Study Treatment | Change in CD4+ T Cell Count | Change from Baseline to Week 5 | -8.19 cells/mm^3 |
Comparison: Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 2.p-value: 0.00790% CI: [57.6, 227]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 5.p-value: 0.1490% CI: [-8.23, 156.7]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in CD4+ T cell counts from Baseline to Week 12.p-value: 0.5490% CI: [-143, 65.5]t-test, 2 sided
Comparison: There is no difference between the two arms in the change in CD4+ T cell counts from Week 5 to Week 12.p-value: 0.1290% CI: [-231, 5.9]t-test, 2 sided
Secondary
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
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in CD69 | Change from Entry to Week 5 | — |
| Unknown | Change in CD69 | Change from Entry to Week 12 | — |
Secondary
Change in Classical Monocytes (CD14+CD16-)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) | Change from Entry to Week 5 | 0.95 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) | Change from Entry to Week 12 | 1.15 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) | Change from Entry to Week 5 | -0.43 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) | Change from Entry to Week 12 | -1.06 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 5.p-value: 0.4790% CI: [-1.83, 4.61]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) from Entry to Week 12.p-value: 0.2290% CI: [-0.77, 5.18]t-test, 2 sided
Secondary
Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Change from Entry to Week 5 | -1.24 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Change from Entry to Week 12 | -0.84 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Change from Entry to Week 5 | -0.43 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CCR2+ | Change from Entry to Week 12 | 0.86 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 5.p-value: 0.5590% CI: [-3.02, 1.41]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CCR2+ from Entry to Week 12.p-value: 0.0990% CI: [-3.36, -0.04]t-test, 2 sided
Secondary
Change in Classical Monocytes (CD14+CD16-) Expressing CD163+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Change from Entry to Week 5 | -1.16 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Change from Entry to Week 12 | -5.05 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Change from Entry to Week 5 | 3.18 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CD163+ | Change from Entry to Week 12 | 4.76 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 5.p-value: 0.2890% CI: [-11, 2.35]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CD163+ from Entry to Week 12.p-value: 0.01990% CI: [-16.6, -3.02]t-test, 2 sided
Secondary
Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+
Absolute change in the percent of classical monocytes (CD14+CD16-) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Change from Entry to Week 5 | -1.72 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Change from Entry to Week 12 | -0.62 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Change from Entry to Week 5 | -0.25 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Classical Monocytes (CD14+CD16-) Expressing CX3CR1+ | Change from Entry to Week 12 | 1.00 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 5.p-value: 0.1590% CI: [-3.17, 0.23]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in classical monocytes (CD14+CD16-) expressing CX3CR1+ from Entry to Week 12.p-value: 0.3790% CI: [-4.59, 1.35]t-test, 2 sided
Secondary
Change in Creatinine Clearance Values From Entry
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 1/2 | -2.16 mL/min |
| Arm A: Ruxolitinib | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 4/5 | -1.17 mL/min |
| Arm A: Ruxolitinib | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 10/12 | -0.71 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 1/2 | -3.47 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 4/5 | -2.78 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Clearance Values From Entry | Change From Entry to Week 10/12 | -7.06 mL/min |
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 1/2.p-value: 0.790% CI: [-4.27, 6.9]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to Week 4/5.p-value: 0.6990% CI: [-5.06, 8.29]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine clearance from Entry to 10/12.p-value: 0.0990% CI: [0.16, 12.5]t-test, 2 sided
Secondary
Change in Creatinine Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Creatinine Values From Entry | Change From Entry to Week 1/2 | 0.01 mL/min |
| Arm A: Ruxolitinib | Change in Creatinine Values From Entry | Change From Entry to Week 4/5 | 0.02 mL/min |
| Arm A: Ruxolitinib | Change in Creatinine Values From Entry | Change From Entry to Week 10/12 | -0.00 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Values From Entry | Change From Entry to Week 1/2 | 0.03 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Values From Entry | Change From Entry to Week 4/5 | 0.03 mL/min |
| Arm B: No Study Treatment | Change in Creatinine Values From Entry | Change From Entry to Week 10/12 | 0.07 mL/min |
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 1/2.p-value: 0.5890% CI: [-0.06, 0.03]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to Week 4/5.p-value: 0.7990% CI: [-0.06, 0.04]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in creatinine from Entry to 10/12.p-value: 0.01690% CI: [-0.11, -0.02]t-test, 2 sided
Secondary
Change in Hemoglobin Values From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Hemoglobin Values From Entry | Change From Entry to Week 1/2 | -0.28 g/dL |
| Arm A: Ruxolitinib | Change in Hemoglobin Values From Entry | Change From Entry to Week 4/5 | -0.65 g/dL |
| Arm A: Ruxolitinib | Change in Hemoglobin Values From Entry | Change From Entry to Week 10/12 | -0.07 g/dL |
| Arm B: No Study Treatment | Change in Hemoglobin Values From Entry | Change From Entry to Week 1/2 | -0.15 g/dL |
| Arm B: No Study Treatment | Change in Hemoglobin Values From Entry | Change From Entry to Week 4/5 | -0.10 g/dL |
| Arm B: No Study Treatment | Change in Hemoglobin Values From Entry | Change From Entry to Week 10/12 | -0.08 g/dL |
Comparison: Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 1/2.p-value: 0.4590% CI: [-0.42, 0.15]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 4/5.p-value: 0.00590% CI: [-0.87, -0.23]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in hemoglobin from Entry to Week 10/12.p-value: 0.7590% CI: [-0.65, 0.95]t-test, 2 sided
Secondary
Change in Inflammatory Monocytes (CD14+CD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) | Change from Entry to Week 5 | -1.21 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) | Change from Entry to Week 12 | -0.49 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) | Change from Entry to Week 5 | -0.36 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) | Change from Entry to Week 12 | 0.22 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 5.p-value: 0.3990% CI: [-2.51, 0.8]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) from Entry to Week 12.p-value: 0.5490% CI: [-2.59, 1.19]t-test, 2 sided
Secondary
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Change from Entry to Week 5 | 2.95 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Change from Entry to Week 12 | -1.99 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Change from Entry to Week 5 | 2.67 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CCR2+ | Change from Entry to Week 12 | 2.11 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 5.p-value: 0.9590% CI: [-7.26, 7.82]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CCR2+ from Entry to Week 12.p-value: 0.4390% CI: [-12.6, 4.45]t-test, 2 sided
Secondary
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+
Absolute change in the percent of inflammatory monocytes (CD14+CD16-) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Change from Entry to Week 5 | -3.88 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Change from Entry to Week 12 | -4.40 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Change from Entry to Week 5 | 2.14 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CD163+ | Change from Entry to Week 12 | 2.00 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 5.p-value: 0.190% CI: [-12, -0.06]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CD163+ from Entry to Week 12.p-value: 0.02690% CI: [-11.1, -1.73]t-test, 2 sided
Secondary
Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+
Absolute change in the percent of inflammatory monocytes (CD14+CD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Change from Entry to Week 5 | -4.38 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Change from Entry to Week 12 | 0.58 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Change from Entry to Week 5 | -5.61 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Inflammatory Monocytes (CD14+CD16+) Expressing CX3CR1+ | Change from Entry to Week 12 | -3.18 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 5.p-value: 0.7490% CI: [-5.08, 7.54]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in inflammatory monocytes (CD14+CD16+) expressing CX3CR1+ from Entry to Week 12.p-value: 0.4290% CI: [-3.94, 11.5]t-test, 2 sided
Secondary
Change in PAR-1
Data not available because the team decided they were no longer clinically relevant, so samples were not tested for PAR-1.
Time frame: Entry, Weeks 5 and 12
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Change in PAR-1 | Change from Entry to Week 5 | — |
| Unknown | Change in PAR-1 | Change from Entry to Week 12 | — |
Secondary
Change in Patrolling Monocytes (CD14dimCD16+)
Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) | Change from Entry to Week 5 | 0.20 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) | Change from Entry to Week 12 | -0.70 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) | Change from Entry to Week 5 | 0.83 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) | Change from Entry to Week 12 | 0.87 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 5.p-value: 0.6690% CI: [-2.99, 1.73]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) from Entry to Week 12.p-value: 0.2790% CI: [-3.93, 0.8]t-test, 2 sided
Secondary
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CCR2+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Change from Entry to Week 5 | 0.02 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Change from Entry to Week 12 | 0.04 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Change from Entry to Week 5 | 0.01 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CCR2+ | Change from Entry to Week 12 | 0.04 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 5.p-value: 0.7990% CI: [-0.05, 0.07]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CCR2+ from Entry to Week 12.p-value: 0.9190% CI: [-0.07, 0.08]t-test, 2 sided
Secondary
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CD163+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Change from Entry to Week 5 | -4.05 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Change from Entry to Week 12 | -1.09 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Change from Entry to Week 5 | 3.05 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CD163+ | Change from Entry to Week 12 | 0.41 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 5.p-value: 0.01390% CI: [-11.7, -2.46]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CD163+ from Entry to Week 12.p-value: 0.790% CI: [-8.06, 5.07]t-test, 2 sided
Secondary
Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+
Absolute change in the percent of patrolling monocytes (CD14dimCD16+) that express CX3CR1+. Absolute change was calculated as the value at week 5 minus the value at entry, and the value at week 12 minus the value at entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Change from Entry to Week 5 | -5.48 Percent of Expression in Parent Cell |
| Arm A: Ruxolitinib | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Change from Entry to Week 12 | -2.39 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Change from Entry to Week 5 | -2.64 Percent of Expression in Parent Cell |
| Arm B: No Study Treatment | Change in Patrolling Monocytes (CD14dimCD16+) Expressing CX3CR1+ | Change from Entry to Week 12 | -2.42 Percent of Expression in Parent Cell |
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 5.p-value: 0.4390% CI: [-8.82, 3.12]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in patrolling monocytes (CD14dimCD16+) expressing CX3CR1+ from Entry to Week 12.p-value: 0.9990% CI: [-6.53, 6.6]t-test, 2 sided
Secondary
Change in Platelet Counts From Entry
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined. Absolute change was calculated as the value at Week 1/2 minus the value at Entry, the value at Week 4/5 minus the value at Entry, and the value at Week 10/12 minus the value at Entry.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Change in Platelet Counts From Entry | Change From Entry to Week 1/2 | 43018 Platelets/mm^3 |
| Arm A: Ruxolitinib | Change in Platelet Counts From Entry | Change From Entry to Week 4/5 | 32435 Platelets/mm^3 |
| Arm A: Ruxolitinib | Change in Platelet Counts From Entry | Change From Entry to Week 10/12 | 8815 Platelets/mm^3 |
| Arm B: No Study Treatment | Change in Platelet Counts From Entry | Change From Entry to Week 1/2 | 5264 Platelets/mm^3 |
| Arm B: No Study Treatment | Change in Platelet Counts From Entry | Change From Entry to Week 4/5 | 4603 Platelets/mm^3 |
| Arm B: No Study Treatment | Change in Platelet Counts From Entry | Change From Entry to Week 10/12 | 3439 Platelets/mm^3 |
Comparison: Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 1/2.p-value: <0.00190% CI: [19609, 55898]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 4/5.p-value: 0.01290% CI: [9849, 45815]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the change in platelet values from Entry to Week 10/12.p-value: 0.5290% CI: [-8592, 19344]t-test, 2 sided
Secondary
Creatinine
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Creatinine | Entry | 0.99 mg/dL |
| Arm A: Ruxolitinib | Creatinine | Week 1/2 | 1.0 mg/dL |
| Arm A: Ruxolitinib | Creatinine | Week 10/12 | 0.99 mg/dL |
| Arm A: Ruxolitinib | Creatinine | Week 4/5 | 1.01 mg/dL |
| Arm B: No Study Treatment | Creatinine | Week 4/5 | 0.95 mg/dL |
| Arm B: No Study Treatment | Creatinine | Entry | 0.92 mg/dL |
| Arm B: No Study Treatment | Creatinine | Week 10/12 | 0.99 mg/dL |
| Arm B: No Study Treatment | Creatinine | Week 1/2 | 0.95 mg/dL |
Secondary
Creatinine Clearance
Creatinine clearance was calculated using the Cockcroft Gault equation. The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Creatinine Clearance | Entry | 118.5 mL/min |
| Arm A: Ruxolitinib | Creatinine Clearance | Week 1/2 | 116.3 mL/min |
| Arm A: Ruxolitinib | Creatinine Clearance | Week 4/5 | 117.3 mL/min |
| Arm A: Ruxolitinib | Creatinine Clearance | Week 10/12 | 117.8 mL/min |
| Arm B: No Study Treatment | Creatinine Clearance | Week 10/12 | 126.6 mL/min |
| Arm B: No Study Treatment | Creatinine Clearance | Entry | 134.5 mL/min |
| Arm B: No Study Treatment | Creatinine Clearance | Week 4/5 | 130.9 mL/min |
| Arm B: No Study Treatment | Creatinine Clearance | Week 1/2 | 130.2 mL/min |
Secondary
Fold Change in Cellular HIV-1 DNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in Cellular HIV-1 DNA | Fold Change from Entry to Week 5 | 1.16 Fold Change |
| Arm A: Ruxolitinib | Fold Change in Cellular HIV-1 DNA | Fold Change from Entry to Week 12 | 1.18 Fold Change |
| Arm B: No Study Treatment | Fold Change in Cellular HIV-1 DNA | Fold Change from Entry to Week 5 | 0.62 Fold Change |
| Arm B: No Study Treatment | Fold Change in Cellular HIV-1 DNA | Fold Change from Entry to Week 12 | 0.90 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 5.p-value: 0.00790% CI: [1.29, 2.73]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Cellular HIV-1 DNA from entry to Week 12.p-value: 0.2390% CI: [0.9, 1.9]t-test, 2 sided
Secondary
Fold Change in Cellular HIV-1 Total RNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in Cellular HIV-1 Total RNA | Fold Change from Entry to Week 5 | 1.06 Fold Change |
| Arm A: Ruxolitinib | Fold Change in Cellular HIV-1 Total RNA | Fold Change from Entry to Week 12 | 0.97 Fold Change |
| Arm B: No Study Treatment | Fold Change in Cellular HIV-1 Total RNA | Fold Change from Entry to Week 5 | 0.87 Fold Change |
| Arm B: No Study Treatment | Fold Change in Cellular HIV-1 Total RNA | Fold Change from Entry to Week 12 | 0.95 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 5.p-value: 0.3290% CI: [0.87, 1.72]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in cellular HIV-1 total RNA from entry to Week 12.p-value: 0.9190% CI: [0.68, 1.56]t-test, 2 sided
Secondary
Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10)
Laboratory testing was not performed so the data are not available.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10) | Fold Change from Baseline to Week 4/5 | — |
| Unknown | Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10) | Fold Change from Baseline to Week 12 | — |
| Unknown | Fold Change in the Level of Interferon Gamma-induced Protein 10 (IP-10) | Fold Change from Week 4/5 to Week 12 | — |
Secondary
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
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha) | Fold Change from Baseline to Week 4/5 | — |
| Unknown | Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha) | Fold Change from Baseline to Week 12 | — |
| Unknown | Fold Change in the Level of Interleukin 1 Alpha (IL-1 Alpha) | Fold Change from Week 4/5 to Week 12 | — |
Secondary
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
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Fold Change in the Level of Macrophage Colony-stimulating Factor | Fold Change from Baseline to Week 4/5 | — |
| Unknown | Fold Change in the Level of Macrophage Colony-stimulating Factor | Fold Change from Baseline to Week 12 | — |
| Unknown | Fold Change in the Level of Macrophage Colony-stimulating Factor | Fold Change from Week 4/5 to Week 12 | — |
Secondary
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
Population: Results not reported.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Fold Change in the Level of Neopterin | Fold Change from Baseline to Week 4/5 | — |
| Unknown | Fold Change in the Level of Neopterin | Fold Change from Baseline to Week 12 | — |
| Unknown | Fold Change in the Level of Neopterin | Fold Change from Week 4/5 to Week 12 | — |
Secondary
Fold Change in the Level of Plasma Interleukin 10 (IL-10)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 10 (IL-10) | Fold Change from Entry to Week 5 | 0.94 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 10 (IL-10) | Fold Change from Entry to Week 12 | 0.65 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 10 (IL-10) | Fold Change from Entry to Week 5 | 0.82 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 10 (IL-10) | Fold Change from Entry to Week 12 | 0.67 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 5.p-value: 0.5690% CI: [0.77, 1.72]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 10 (IL-10) from entry to Week 12.p-value: 0.9590% CI: [0.47, 2.01]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Interleukin 15 (IL-15)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 15 (IL-15) | Fold Change from Entry to Week 5 | 1.33 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 15 (IL-15) | Fold Change from Entry to Week 12 | 1.06 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 15 (IL-15) | Fold Change from Entry to Week 5 | 0.99 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 15 (IL-15) | Fold Change from Entry to Week 12 | 0.98 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 5.p-value: 0.00290% CI: [1.15, 1.56]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in TInterleukin 15 (IL-15) from entry to Week 12.p-value: 0.690% CI: [0.86, 1.34]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Interleukin 18 (IL-18)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 18 (IL-18) | Fold Change from Entry to Week 5 | 0.89 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 18 (IL-18) | Fold Change from Entry to Week 12 | 1.05 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 18 (IL-18) | Fold Change from Entry to Week 5 | 0.95 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 18 (IL-18) | Fold Change from Entry to Week 12 | 1.02 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 5.p-value: 0.490% CI: [0.82, 1.07]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 18 (IL-18) from entry to Week 12.p-value: 0.8290% CI: [0.83, 1.27]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | Fold Change from Entry to Week 5 | 0.96 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | Fold Change from Entry to Week 12 | 1.24 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | Fold Change from Entry to Week 5 | 0.75 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 1 Beta (IL-1 Beta) | Fold Change from Entry to Week 12 | 0.78 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 5.p-value: 0.390% CI: [0.87, 1.86]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 1 beta (IL-1 beta) from entry to Week 12.p-value: 0.4690% CI: [0.56, 4.49]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Interleukin 6 (IL-6)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Week 10/12 is defined as the geometric mean of the Week 10 and Week 12 values. Fold change was calculated as the value at Week 10/12 divided by the value at Baseline and the value at Week 4/5 divided by the value at Week 10/12.
Time frame: Pre-entry, Entry, Weeks 4, 5, 10 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 6 (IL-6) | Fold Change from Baseline to Week 10/12 | 1.16 Fold Change |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 6 (IL-6) | Fold Change from Baseline to Week 10/12 | 1.06 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 6 (IL-6) | Fold Change from Week 4/5 to Week 10/12 | 0.92 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from baseline to Week 10/12.p-value: 0.5690% CI: [0.84, 1.44]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Plasma Interleukin 6 (IL-6) from Week 4/5 to Week 10/12.p-value: 0.02690% CI: [1.09, 1.73]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Interleukin 7 (IL-7)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 7 (IL-7) | Fold Change from Entry to Week 5 | 1.04 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Interleukin 7 (IL-7) | Fold Change from Entry to Week 12 | 1.23 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 7 (IL-7) | Fold Change from Entry to Week 5 | 0.81 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Interleukin 7 (IL-7) | Fold Change from Entry to Week 12 | 1.04 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 5.p-value: 0.2490% CI: [0.9, 1.84]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Interleukin 7 (IL-7) from entry to Week 12.p-value: 0.4690% CI: [0.81, 1.74]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1) | Fold Change from Entry to Week 5 | 0.60 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 1 (TGF Beta-1) | Fold Change from Entry to Week 12 | 0.93 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 5.p-value: 0.02890% CI: [1.11, 2.02]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 1 (TGF beta-1) from entry to Week 12.p-value: 0.2190% CI: [0.79, 5.25]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2) | Fold Change from Entry to Week 5 | 0.69 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 2 (TGF Beta-2) | Fold Change from Entry to Week 12 | 0.94 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 5.p-value: 0.03190% CI: [1.08, 1.79]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 2 (TGF beta-2) from entry to Week 12.p-value: 0.9390% CI: [0.46, 2.02]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3) | Fold Change from Entry to Week 5 | 0.63 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Transforming Growth Factor Beta 3 (TGF Beta-3) | Fold Change from Entry to Week 12 | 0.99 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 5.p-value: 0.4390% CI: [0.61, 4.05]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Transforming Growth Factor beta 3 (TGF beta-3) from entry to Week 12.p-value: 0.4190% CI: [0.3, 1.5]t-test, 2 sided
Secondary
Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | Fold Change from Entry to Week 5 | 0.79 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | Fold Change from Entry to Week 12 | 0.85 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | Fold Change from Entry to Week 5 | 0.90 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Plasma Tumor Necrosis Factor Alpha (TNF Alpha) | Fold Change from Entry to Week 12 | 0.92 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 5.p-value: 0.1190% CI: [0.76, 1.01]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Tumor Necrosis Factor alpha (TNF alpha) from entry to Week 12.p-value: 0.7190% CI: [0.64, 1.33]t-test, 2 sided
Secondary
Fold Change in the Level of Soluble CD14 (sCD14)
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Baseline is defined as the geometric mean of the Pre-entry and Entry values. Week 4/5 is defined as the geometric mean of the Week 4 and Week 5 values. Fold change was calculated as the value at Week 4/5 divided by the value at Baseline, the value at Week 12 divided by the value at Baseline, and the value at Week 12 divided by the value at Week 4/5.
Time frame: Pre-entry, Entry, Weeks 4, 5, and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Baseline to Week 4/5 | 0.96 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Baseline to Week 12 | 1.02 Fold Change |
| Arm A: Ruxolitinib | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Week 4/5 to Week 12 | 1.08 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Baseline to Week 4/5 | 1.08 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Baseline to Week 12 | 1.08 Fold Change |
| Arm B: No Study Treatment | Fold Change in the Level of Soluble CD14 (sCD14) | Fold Change from Week 4/5 to Week 12 | 1.02 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 4/5.p-value: 0.0790% CI: [0.8, 0.99]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from baseline to Week 12.p-value: 0.5990% CI: [0.8, 1.12]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in soluble CD14 (sCD14) from Week 4/5 to Week 12.p-value: 0.5690% CI: [0.9, 1.24]t-test, 2 sided
Secondary
Hemoglobin
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Hemoglobin | Entry | 14.3 g/dL |
| Arm A: Ruxolitinib | Hemoglobin | Week 1/2 | 14.0 g/dL |
| Arm A: Ruxolitinib | Hemoglobin | Week 4/5 | 13.6 g/dL |
| Arm A: Ruxolitinib | Hemoglobin | Week 10/12 | 14.4 g/dL |
| Arm B: No Study Treatment | Hemoglobin | Week 10/12 | 14.2 g/dL |
| Arm B: No Study Treatment | Hemoglobin | Entry | 14.3 g/dL |
| Arm B: No Study Treatment | Hemoglobin | Week 4/5 | 14.2 g/dL |
| Arm B: No Study Treatment | Hemoglobin | Week 1/2 | 14.1 g/dL |
Secondary
Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point.
Protocol-defined reportable adverse events include: all diagnoses regardless of grade, Grade 3 or higher sign/symptoms or laboratory values, any signs/symptoms or laboratory values that led to a change in treatment or met ICH, EAE, or SAE guidelines. See the Protocol Section References for links to the EAE manual. This is a subset of the events reported in the Adverse Events section.
Time frame: Entry to Week 12
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm A: Ruxolitinib | Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point. | 10 Participants |
| Arm B: No Study Treatment | Number of Participants Who Experienced a Protocol-defined Reportable Adverse Event at Any Post-entry Time Point. | 2 Participants |
Secondary
Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification
Participants were required to be virally suppressed, with a plasma HIV-1 RNA level below 40 copies/mL. The number of participants with plasma HIV-1 RNA level above the limit of quantification is reported at each time point.
Time frame: Entry, Weeks 2, 5, and 12
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm A: Ruxolitinib | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 2 | 0 Participants |
| Arm A: Ruxolitinib | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 12 | 1 Participants |
| Arm A: Ruxolitinib | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 5 | 2 Participants |
| Arm A: Ruxolitinib | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Entry | 1 Participants |
| Arm B: No Study Treatment | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 5 | 0 Participants |
| Arm B: No Study Treatment | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 2 | 0 Participants |
| Arm B: No Study Treatment | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Entry | 0 Participants |
| Arm B: No Study Treatment | Number of Participants With Plasma HIV-1 RNA Level Above the Limit of Quantification | Week 12 | 0 Participants |
Secondary
Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Discontinuation of Ruxolitinib due to thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity related to study drug Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ruxolitinib | Percentage of Participants on the Ruxolitinib Arm Who Experienced Any Safety Milestone Events During Total Follow-up | 7.5 percentage of participants |
Secondary
Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12
Events defined as safety milestones are listed below and together makeup the composite endpoint. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm\^3 (for participants with entry CD4+ T cell count \< 700 cells/mm\^3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm\^3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing a safety milestone will be reported.
Time frame: Entry to Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A: Ruxolitinib | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12 | 7.5 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Any Safety Milestones On-study From Entry to Week 12 | 0 percentage of participants |
Comparison: Null hypothesis: There is no difference between the two arms in the percentage of participants experiencing safety milestones from Entry to Week 12.p-value: 0.4Fisher Exact
Secondary
Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12
Events defined as safety milestones are listed below. * Confirmed CD4+ decline \> 33% of entry and to \< 350 cell/mm3 (for participants with entry CD4+ T cell count \< 700 cells/mm3) * Confirmed CD4+ decline \> 50% of entry (for participants with entry CD4+ T cell count ≥ 700 cells/mm3) * Confirmed HIV-1 RNA level above the lower limit of quantification in the absence of an interruption of ART * New or recurrent CDC category C AIDS-indicator condition * HIV-1 associated infection including Herpes zoster * Lymphoproliferative malignancies * Grade 4 or recurrence of Grade 3 anemia/neutropenia * New diagnosis of pneumonia, sepsis, or bacteremia * Occurrence of Grade 2 or higher thrombocytopenia * Any Grade 4 or recurrence of Grade 3 toxicity Percent experiencing each safety milestone will be reported. Safety milestone categories are not mutually exclusive.
Time frame: Entry to Week 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | Lymphoproliferative malignancies | 0 percentage of participants |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | New diagnosis of pneumonia, sepsis, or bacteremia | 0 percentage of participants |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | Lymphoproliferative malignancies | 0 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants Who Experienced Each Safety Milestone That Occurred On-study From Entry to Week 12 | Confirmed CD4+ decline > 50% of entry | 0 percentage of participants |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 | 0 percentage of participants |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
| Arm B: No Study Treatment | 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 |
Secondary
Percentage of Participants With Detectable CMV Shedding
Level of CMV shedding was summarized by study week and arm as the percentage of those above and below the assay limit of detection. Detectable CMV shedding was defined as CMV level \> 0 copies/ml of elution. The percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5) and any post-treatment time point (ever shedding at weeks 10 or 12) was contrasted between study arms.
Time frame: Pre-entry, Entry, and Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Pre-entry | 13 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Entry | 13 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 1 | 13 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 2 | 8 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 4 | 8 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 5 | 5 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 10 | 5 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Week 12 | 20 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Any Detectable CMV On-treatment | 18 percentage of participants |
| Arm A: Ruxolitinib | Percentage of Participants With Detectable CMV Shedding | Any Detectable CMV Post-treatment | 20 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 12 | 16 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Pre-entry | 5 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 5 | 16 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Entry | 10 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Any Detectable CMV Post-treatment | 16 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 1 | 11 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 10 | 11 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 2 | 16 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Any Detectable CMV On-treatment | 26 percentage of participants |
| Arm B: No Study Treatment | Percentage of Participants With Detectable CMV Shedding | Week 4 | 6 percentage of participants |
Comparison: Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any on-treatment time point (ever shedding at weeks 1, 2, 4, or 5).p-value: 0.4Fisher Exact
Comparison: Null hypothesis: There is no difference between the two arms in the percentage of participants with detectable CMV at any post-treatment time point (ever shedding at weeks 10 or 12).p-value: 0.87Fisher Exact
Secondary
Platelet Count
The arithmetic mean for each participant was calculated at week 1 and week 2 combined, week 4 and week 5 combined, and week 10 and week 12 combined.
Time frame: Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Platelet Count | Entry | 238508 Platelets/mm^3 |
| Arm A: Ruxolitinib | Platelet Count | Week 1/2 | 281525 Platelets/mm^3 |
| Arm A: Ruxolitinib | Platelet Count | Week 4/5 | 270943 Platelets/mm^3 |
| Arm A: Ruxolitinib | Platelet Count | Week 10/12 | 247323 Platelets/mm^3 |
| Arm B: No Study Treatment | Platelet Count | Week 10/12 | 261184 Platelets/mm^3 |
| Arm B: No Study Treatment | Platelet Count | Entry | 261868 Platelets/mm^3 |
| Arm B: No Study Treatment | Platelet Count | Week 4/5 | 264155 Platelets/mm^3 |
| Arm B: No Study Treatment | Platelet Count | Week 1/2 | 264492 Platelets/mm^3 |
Secondary
Relative Risks of HIV-1 RNA by Single Copy Assay (SCA) < 0.4 Copies/mL
HIV-1 RNA was measured via Single Copy Assay Using Primer in Integrase (iSCA), results were reported as below or above the assay limit of detection (LOD) (LOD = 0.4 copies/mL). GEE models for binary data were used to calculate the relative risk of having HIV-1 RNA by iSCA \<0.4 copies/mL (Week 5 compared to Entry, Week 12 compared to Entry, and Week 12 compared to Week 5).
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm A: Ruxolitinib | 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 |
| Arm B: No Study Treatment | 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 | 1.22 Relative Risk |
| Arm B: No Study Treatment | 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 | 1.11 Relative Risk |
| Arm B: No Study Treatment | 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 | 0.91 Relative Risk |
Comparison: Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 5.p-value: 0.9490% CI: [0.65, 1.49]GEE
Comparison: Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Entry to Week 12.p-value: 0.4690% CI: [0.37, 1.46]GEE
Comparison: Null hypothesis: There is no difference between the two arms in the change in HIV-1 RNA by iSCA from Week 5 to Week 12.p-value: 0.5990% CI: [0.46, 1.48]GEE
Secondary
Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK)
Ruxolitinib plasma concentrations were fitted to a population 2-compartment distribution model, assuming first-order input, distribution and elimination from the plasma compartment, using nonlinear mixed-effects modeling software. We estimated parameter geometric means and proportional variabilities between subjects (IIV when feasible) and the variability in drug absorption between occasions (IOV week 1 and week 4/5), and related distribution volumes to body weight.
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
Population: Analysis was done on participants on the Ruxolitinib arm with intensive pharmacokinetic (PK) results. One participant was not included due to missing samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm A: Ruxolitinib | Ruxolitinib Systemic Clearance (CL/F) From 2-compartment Pharmacokinetic (PK) | 14.5 L/hr | Geometric Coefficient of Variation 34 |
Other Pre-specified
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
Population: Results not reported.
Other Pre-specified
Fold Change in Integrated DNA
All values were log10 transformed prior to calculating change and conducting analyses and back transformed for presentation. Fold change was calculated as the value at Week 5 divided by the value at Entry and the value at Week 12 divided by the value at Entry.
Time frame: Entry, Weeks 5 and 12
Population: 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).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm A: Ruxolitinib | Fold Change in Integrated DNA | Fold Change from Entry to Week 5 | 1.10 Fold Change |
| Arm A: Ruxolitinib | Fold Change in Integrated DNA | Fold Change from Entry to Week 12 | 1.11 Fold Change |
| Arm B: No Study Treatment | Fold Change in Integrated DNA | Fold Change from Entry to Week 5 | 2.06 Fold Change |
| Arm B: No Study Treatment | Fold Change in Integrated DNA | Fold Change from Entry to Week 12 | 1.20 Fold Change |
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 5.p-value: 0.490% CI: [0.15, 1.88]t-test, 2 sided
Comparison: Null hypothesis: There is no difference between the two arms in the fold change in Integrated DNA from entry to Week 12.p-value: 0.9390% CI: [0.2, 4.34]t-test, 2 sided
Other Pre-specified
Level of HHV Shedding (EBV, HSV, HHV-6, HHV-7, and HHV-8)
Data not available because no samples were collected to test for these measures as the team decided they were no longer clinically relevant.
Time frame: Pre-entry, Entry, Weeks 1, 2, 4, 5, 10, and 12
Population: Results not reported.