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A Safety Study of Brentuximab Vedotin in Participants With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05244473
Recruitment Status : Withdrawn (Study withdrawn due to low patient accrual.)
First Posted : February 17, 2022
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Drug: brentuximab vedotin Drug: Placebo Drug: ART Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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)
Estimated Study Start Date : December 31, 2022
Estimated Primary Completion Date : May 31, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Brentuximab vedotin + ART
Brentuximab vedotin given on Day 1 and Day 15. ART will be given throughout the study.
 Drug: brentuximab vedotin
Given into the vein (IV; intravenously)
Other Name: ADCETRIS

Drug: ART
Daily use of a combination of HIV medicines
Placebo Comparator: Placebo + ART
Placebo given on Day 1 and Day 15. ART will be given throughout the study.
 Drug: Placebo
Given by IV

Drug: ART
Daily use of a combination of HIV medicines


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events (AEs) [ Time Frame: Through 30 days after last study treatment ]
    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

  2. Number of participants with laboratory abnormalities [ Time Frame: Approximately 1 year ]
  3. Number of participants with dose-limiting toxicities (DLTs) by dose level [ Time Frame: Up to 30 days ]

Secondary Outcome Measures :
  1. Area under the concentration-time curve (AUC) [ Time Frame: Approximately 4 months ]
    Pharmacokinetic (PK) Parameter

  2. Maximum concentration (Cmax) [ Time Frame: Approximately 4 months ]
    PK Parameter

  3. Time to maximum concentration (Tmax) [ Time Frame: Approximately 4 months ]
    PK Parameter

  4. Apparent terminal half-life (t1/2) [ Time Frame: Approximately 4 months ]
    PK Parameter

  5. Trough concentration (Ctrough) [ Time Frame: Approximately 4 months ]
    PK Parameter

  6. Incidence of antidrug antibodies (ADAs) [ Time Frame: Approximately 4 months ]
  7. Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL [ Time Frame: Approximately 1 year ]
  8. Proportion of participants with CD4+ T-cell lymphocyte count >200 cells/µL, with a minimum increase of 50 cells/µL [ Time Frame: Approximately 1 year ]
  9. Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL [ Time Frame: Approximately 1 year ]
    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

  10. Duration of CD4+ T-cell lymphocyte count increases >200 cells/µL with a minimum increase of 50 cells/µL [ Time Frame: Approximately 1 year ]
    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

  11. Change from baseline in CD4+ T-cell lymphocyte counts [ Time Frame: Approximately 1 year ]
    The change from baseline in CD4+ T-cell lymphocyte counts will be summarized based on observed values.

  12. Change from baseline in CD4+ T cell percentage [ Time Frame: Approximately 1 year ]
    The change from baseline in CD4+ T cell percentage will be summarized based on observed values.

  13. Change from baseline in CD8+ T-cell lymphocyte counts [ Time Frame: Approximately 1 year ]
    The change from baseline CD8+ T-cell lymphocyte counts will be summarized based on observed values.

  14. Change from baseline in CD4:CD8 ratio [ Time Frame: Approximately 1 year ]
    The change from baseline in CD4:CD8 ratio will be summarized.

  15. Change from baseline in Treg and other T-cell subsets [ Time Frame: Approximately 6 months ]
  16. Proportion of subjects with HIV viral load <50 copies/mL [ Time Frame: Approximately 1 year ]
    The proportion of subjects with HIV viral load <50 copies/mL will be summarized.

  17. Proportion of subjects with fatal or non-fatal acquired immunodeficiency syndrome (AIDS) related opportunistic disease or death from any cause [ Time Frame: Approximately 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05244473


Locations
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United States, California
University of California at San Francisco
San Francisco, California, United States, 94110
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Andrei Shustov, MD Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT05244473    
Other Study ID Numbers: SGN35-035
First Posted: February 17, 2022    Key Record Dates
Last Update Posted: February 14, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
HIV
Immunological Nonresponder
Seattle Genetics
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
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
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents