A Safety Study of Brentuximab Vedotin in Participants With HIV

NCT05244473 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: SGN35-035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Human Immunodeficiency Virus

Keywords

HIV; Immunological Nonresponder; Seattle Genetics

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events (AEs)

  Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment

  Through 30 days after last study treatment

• Number of participants with laboratory abnormalities

  Approximately 1 year

• Number of participants with dose-limiting toxicities (DLTs) by dose level

  Up to 30 days

Secondary Outcomes (17)

• Area under the concentration-time curve (AUC)

  Approximately 4 months

• Maximum concentration (Cmax)

  Approximately 4 months

• Time to maximum concentration (Tmax)

  Approximately 4 months

• Apparent terminal half-life (t1/2)

  Approximately 4 months

• Trough concentration (Ctrough)

  Approximately 4 months

Study Arms (2)

Brentuximab vedotin + ART

EXPERIMENTAL

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

Drug: brentuximab vedotin; Drug: ART

Placebo + ART

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: ART

Interventions

brentuximab vedotin DRUG

Given into the vein (IV; intravenously)

Also known as: ADCETRIS

Brentuximab vedotin + ART

Placebo DRUG

Given by IV

Placebo + ART

ART DRUG

Daily use of a combination of HIV medicines

Brentuximab vedotin + ART; Placebo + ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Seagen Inc.: lead

Study Sites (2)

University of California at San Francisco

San Francisco, California, 94110, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Andrei Shustov, MD

  Seagen Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: December 31, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

US (2)