A Phase 1, Single-blind, Dose-escalation Study to Assess the Safety and Tolerability of Brentuximab Vedotin (ADCETRIS®) in Subjects With Human Immunodeficiency Virus (HIV)

SGN35-035

This study will test brentuximab vedotin to see if it is safe for people with human immunodeficiency virus (HIV) who have low CD4+ and have received antiretroviral therapy (ART) treatment. It will also see if brentuximab vedotin raises CD4+ counts. It will study the side effects of this drug as well. A side effect is anything a drug does to the body besides treating the disease. In this study participants will be assigned randomly to a group. Participants will get either brentuximab vedotin or placebo. A placebo looks like the drug but does not contain any medicine in it. All participants will keep getting ART during the study.

2022-12-31

2024-05-31

2024-05-31

Withdrawn

Early phase I

Inclusion Criteria: * 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) Exclusion Criteria: * 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 clinical John Cunningham virus (JCV) infection, history of JCV identified in cerebrospinal fluid, or presence of JCV antibodies at screening * Cirrhosis secondary to any cause * Any immunomodulating therapy (excluding premedication steroid) within 4 weeks prior to the screening visit * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-02-14