Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Timothy Henrich, MD
Headshot of Timothy Henrich
Timothy Henrich

Description

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.

Official Title

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)

Keywords

Human Immunodeficiency Virus, HIV, Immunological Nonresponder, Seattle Genetics, Acquired Immunodeficiency Syndrome, HIV Infections, Immunologic Deficiency Syndromes, Brentuximab Vedotin, ART, Brentuximab vedotin + ART

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • University of California at San Francisco accepting new patients
    San Francisco California 94110 United States
  • University of Illinois at Chicago accepting new patients
    Chicago Illinois 60612 United States

Lead Scientist at UCSF

  • Timothy Henrich, MD
    My laboratory/research group specializes in immunmodulatory, cytoreductive chemotherapeutic and stem cell transplantation approaches to HIV-1 cure. We are also involved in the design and implementation of novel nano/microtechnologies and PET-based imaging approaches to characterize viral reservoirs.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT05244473
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 48 study participants
Last Updated