NCT05244473

A Safety Study of Brentuximab Vedotin in Participants With HIV

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• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Given into the vein (IV; intravenously)
DRUG	Placebo	Given by IV
DRUG	ART	Daily use of a combination of HIV medicines

Timeline

• Start date: 2022-12-31
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2022-02-17
• Last updated: 2023-02-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study