| • Confirmed CD4+ T-cell decline (>33% of baseline and to <350 cells/μL for participants with entry CD4+ T-cell count <700 cells/μL; >50% of baseline for participants with entry CD4+ T-cell count ≥700 cells/μL) |
| • Virologic failure (confirmed HIV-1 RNA level >200 copies/mL in the absence of ART interruption) |
| • New or recurrent CDC category C AIDS-indicator condition |
| • HIV-associated infection including: |
| ◦ Cytomegalovirus end-organ disease |
| ◦ Varicella zoster |
| ◦ Epstein-Barr virus–related clinical disease |
| • Confirmed grade 3 or higher treatment-limiting toxicity |
| • Lymphoproliferative malignancy |
| • Pulmonary toxicity (grade 3 or 4 dyspnea, cough, shortness of breath related to the study drug without other clinical causes) |
| • Confirmed CD4+ T-cell decline (>33% of baseline and to <350 cells/μL for participants with entry CD4+ T-cell count <700 cells/μL; >50% of baseline for participants with entry CD4+ T-cell count ≥700 cells/μL) |
| • Virologic failure (confirmed HIV-1 RNA level >200 copies/mL in the absence of ART interruption) |
| • New or recurrent CDC category C AIDS-indicator condition |
| • HIV-associated infection including: |
| ◦ Cytomegalovirus end-organ disease |
| ◦ Varicella zoster |
| ◦ Epstein-Barr virus–related clinical disease |
| • Confirmed grade 3 or higher treatment-limiting toxicity |
| • Lymphoproliferative malignancy |
| • Pulmonary toxicity (grade 3 or 4 dyspnea, cough, shortness of breath related to the study drug without other clinical causes) |
All potential safety events were reviewed by an independent endpoint review committee, which included a rheumatologist and HIV physician.
Abbreviations: ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; HIV, human immunodeficiency virus; HIV-1, human immunodeficiency virus type 1.
| • Confirmed CD4+ T-cell decline (>33% of baseline and to <350 cells/μL for participants with entry CD4+ T-cell count <700 cells/μL; >50% of baseline for participants with entry CD4+ T-cell count ≥700 cells/μL) |
| • Virologic failure (confirmed HIV-1 RNA level >200 copies/mL in the absence of ART interruption) |
| • New or recurrent CDC category C AIDS-indicator condition |
| • HIV-associated infection including: |
| ◦ Cytomegalovirus end-organ disease |
| ◦ Varicella zoster |
| ◦ Epstein-Barr virus–related clinical disease |
| • Confirmed grade 3 or higher treatment-limiting toxicity |
| • Lymphoproliferative malignancy |
| • Pulmonary toxicity (grade 3 or 4 dyspnea, cough, shortness of breath related to the study drug without other clinical causes) |
| • Confirmed CD4+ T-cell decline (>33% of baseline and to <350 cells/μL for participants with entry CD4+ T-cell count <700 cells/μL; >50% of baseline for participants with entry CD4+ T-cell count ≥700 cells/μL) |
| • Virologic failure (confirmed HIV-1 RNA level >200 copies/mL in the absence of ART interruption) |
| • New or recurrent CDC category C AIDS-indicator condition |
| • HIV-associated infection including: |
| ◦ Cytomegalovirus end-organ disease |
| ◦ Varicella zoster |
| ◦ Epstein-Barr virus–related clinical disease |
| • Confirmed grade 3 or higher treatment-limiting toxicity |
| • Lymphoproliferative malignancy |
| • Pulmonary toxicity (grade 3 or 4 dyspnea, cough, shortness of breath related to the study drug without other clinical causes) |
All potential safety events were reviewed by an independent endpoint review committee, which included a rheumatologist and HIV physician.
Abbreviations: ART, antiretroviral therapy; CDC, Centers for Disease Control and Prevention; HIV, human immunodeficiency virus; HIV-1, human immunodeficiency virus type 1.
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