A Safety Study of Brentuximab Vedotin in Participants With HIV

Human Immunodeficiency Virus Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05244473
• Other study ID #: SGN35-035
• Status: Withdrawn
• Phase: Phase 1
• Start date: December 31, 2022
• Est. completion date: May 31, 2024

Study information

• Verified date: February 2023
• Source: Seagen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes

Intervention

Drug:
• brentuximab vedotin
Given into the vein (IV; intravenously)
• Placebo
Given by IV
• ART
Daily use of a combination of HIV medicines

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of California at San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with laboratory abnormalities		Approximately 1 year
Primary	Number of participants with dose-limiting toxicities (DLTs) by dose level		Up to 30 days
Secondary	Area under the concentration-time curve (AUC)	Pharmacokinetic (PK) Parameter	Approximately 4 months
Secondary	Maximum concentration (Cmax)	PK Parameter	Approximately 4 months
Secondary	Time to maximum concentration (Tmax)	PK Parameter	Approximately 4 months
Secondary	Apparent terminal half-life (t1/2)	PK Parameter	Approximately 4 months
Secondary	Trough concentration (Ctrough)	PK Parameter	Approximately 4 months
Secondary	Incidence of antidrug antibodies (ADAs)		Approximately 4 months
Secondary	Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL		Approximately 1 year
Secondary	Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL, with a minimum increase of 50 cells/µL		Approximately 1 year
Secondary	Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL	The time from start of the first occurrence of CD4+ T-cell count increases to the level >200 cells/µL to the first occurrence of CD4+ T-cell count to the level <200 cells/µL	Approximately 1 year
Secondary	Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL with a minimum increase of 50 cells/µL	The time from start of the first occurrence of CD4+ T-cell count increases to the level >200 cells/µL to the first occurrence of CD4+ T-cell count to the level <200 cells/µL with a minimum increase of 50 cells/µL	Approximately 1 year
Secondary	Change from baseline in CD4+ T-cell lymphocyte counts	The change from baseline in CD4+ T-cell lymphocyte counts will be summarized based on observed values.	Approximately 1 year
Secondary	Change from baseline in CD4+ T cell percentage	The change from baseline in CD4+ T cell percentage will be summarized based on observed values.	Approximately 1 year
Secondary	Change from baseline in CD8+ T-cell lymphocyte counts	The change from baseline CD8+ T-cell lymphocyte counts will be summarized based on observed values.	Approximately 1 year
Secondary	Change from baseline in CD4:CD8 ratio	The change from baseline in CD4:CD8 ratio will be summarized.	Approximately 1 year
Secondary	Change from baseline in Treg and other T-cell subsets		Approximately 6 months
Secondary	Proportion of subjects with HIV viral load <50 copies/mL	The proportion of subjects with HIV viral load <50 copies/mL will be summarized.	Approximately 1 year
Secondary	Proportion of subjects with fatal or non-fatal acquired immunodeficiency syndrome (AIDS) related opportunistic disease or death from any cause		Approximately 1 year