A Safety Study of Brentuximab Vedotin in Participants With HIV
NCT ID: NCT05244473
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2022-12-31
2024-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Brentuximab vedotin + ART
Brentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study.
brentuximab vedotin
Given into the vein (IV; intravenously)
ART
Daily use of a combination of HIV medicines
Placebo + ART
Placebo given on Day 1 and Day 15. ART will be given throughout the study.
Placebo
Given by IV
ART
Daily use of a combination of HIV medicines
Interventions
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brentuximab vedotin
Given into the vein (IV; intravenously)
Placebo
Given by IV
ART
Daily use of a combination of HIV medicines
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andrei Shustov, MD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of California at San Francisco
San Francisco, California, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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SGN35-035
Identifier Type: -
Identifier Source: org_study_id
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