Status:
WITHDRAWN
A Safety Study of Brentuximab Vedotin in Participants With HIV
Lead Sponsor:
Seagen Inc.
Conditions:
Human Immunodeficiency Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 als...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05244473
Start Date
December 31 2022
End Date
May 31 2024
Last Update
February 14 2023
Active Locations (2)
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1
University of California at San Francisco
San Francisco, California, United States, 94110
2
University of Illinois at Chicago
Chicago, Illinois, United States, 60612