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)

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    48
  • sponsor
    Seagen Inc.
Updated on 27 October 2022
immunodeficiency
antiretroviral therapy
hepatitis
hiv viral load

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 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.

Details
Condition Human Immunodeficiency Virus
Treatment Placebo, brentuximab vedotin, ART
Clinical Study IdentifierNCT05244473
SponsorSeagen Inc.
Last Modified on27 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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