A Safety Study of Brentuximab Vedotin in Participants With HIV

Seagen

Status and phase: Withdrawn; Phase 1

Conditions: Human Immunodeficiency Virus

Treatments: Drug: brentuximab vedotin; Drug: Placebo; Drug: ART

Study type: Interventional

Funder types: Industry

Identifiers

NCT05244473

SGN35-035

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Brentuximab vedotin + ART

Experimental group

Description:

Brentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study.

Treatment:

Drug: brentuximab vedotin

Drug: ART

Placebo + ART

Placebo Comparator group

Description:

Placebo given on Day 1 and Day 15. ART will be given throughout the study.

Treatment:

Drug: Placebo

Drug: ART