A Safety Study of Brentuximab Vedotin in Participants With HIV

Ki vehet részt

• HIV-1 seropositive with documentation of infection
• Immunological nonresponder, defined as:; Has been on ART with an HIV viral load <50 copies/mL for at least 24 months; Has a CD4+ T-cell lymphocyte count between 51 to 200 cells/µL
• Life expectancy of >9 months
• Participant is negative for hepatitis B, or if infected with hepatitis B, receiving anti-hepatitis B therapy
• Participants with a history of hepatitis C virus (HCV) are eligible if they have completed therapy for HCV and show sustained virologic remission (12 weeks or more)

Ki nem vehet részt

• Prior clinical John Cunningham virus (JCV) infection, history of JCV identified in cerebrospinal fluid, or presence of JCV antibodies at screening
• Any immunomodulating therapy (excluding premedication steroid) within 4 weeks prior to the screening visit
• Any currently active AIDS-defining illness per Category C conditions according to the CDC Classification System for HIV Infection, with the following exceptions:; Limited cutaneous Kaposi's sarcoma not currently requiring systemic therapy; Wasting syndrome due to HIV or any other AIDS-defining illness for which no therapeutic treatment is required OR the required treatment is not included in the list of prohibited medications
• Acute liver disease or any other active infection secondary to HIV requiring acute therapy
• History of progressive multifocal leukoencephalopathy (PML)
• Prior malignancy within 2 years other than cutaneous basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, anal intraepithelial neoplasia, or cutaneous Kaposi's sarcoma
• Cirrhosis secondary to any cause