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A Safety Study of Brentuximab Vedotin in Participants With HIV

NCT05244473 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-02-14

No results posted yet for this study

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

DRUG

brentuximab vedotin

Given into the vein (IV; intravenously)

DRUG

Placebo

Given by IV

DRUG

ART

Daily use of a combination of HIV medicines

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Andrei Shustov, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244473 on ClinicalTrials.gov