Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06032546




Registration number
NCT06032546
Ethics application status
Date submitted
5/09/2023
Date registered
13/09/2023

Titles & IDs
Public title
A Study to Assess Change in Disease Activity, Adverse Events, and How the Drug Moves Through the Body in Adult Participants Living With Human Immunodeficiency Virus (HIV) Receiving Intravenous (IV) Infusion or Subcutaneous (SC) Injection of Budigalimab and/or ABBV-382
Scientific title
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living With HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption
Secondary ID [1] 0 0
2023-505900-53-00
Secondary ID [2] 0 0
M19-965
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immuno-deficiency Virus (HIV) Disease 0 0
Condition category
Condition code
Infection 0 0 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Budigalimab
Treatment: Drugs - Placebo for Budigalimab
Treatment: Drugs - ABBV-382
Treatment: Drugs - Placebo for ABBV-382
Treatment: Drugs - Budigalimab

Placebo comparator: Arm A: Placebo - Participants will receive budigalimab placebo on Day 1, and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo on Day 1 and Weeks 4 and 8.

Experimental: Arm B: Budigalimab Dose A - Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 matching placebo Day 1 and Weeks 4 and 8.

Experimental: Arm C: ABBV-382 Dose A - Participants will receive budigalimab placebo on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.

Experimental: Arm D: Budigalimab Dose A + ABBV-382 Dose B - Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose B on Day 1 and Weeks 4 and 8.

Experimental: Arm E: Budigalimab Dose A + ABBV-382 Dose A - Participants will receive budigalimab Dose A on Day 1 and Weeks 2, 4, and 6 in combination with ABBV-382 Dose A on Day 1 and Weeks 4 and 8.

Experimental: Arm F: Budigalimab Dose B - Participants will receive open-label budigalimab Dose B on Day 1 and Weeks 2, 4, and 6 (Note, no ABBV-382 or placebo will be administered).


Treatment: Drugs: Budigalimab
Intravenous (IV) Infusion

Treatment: Drugs: Placebo for Budigalimab
IV Infusion

Treatment: Drugs: ABBV-382
IV Infusion

Treatment: Drugs: Placebo for ABBV-382
IV Infusion

Treatment: Drugs: Budigalimab
Subcutaneous (SC) Injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately Week 112
Secondary outcome [1] 0 0
Median Peak Viral Load (At Rebound) Prior to Re-Starting ART
Timepoint [1] 0 0
Up to 112 weeks
Secondary outcome [2] 0 0
Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption
Timepoint [2] 0 0
Up to 112 weeks

Eligibility
Key inclusion criteria
* A condition of general good health in the opinion of the investigator, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
* Must be on antiretroviral therapy (ART) for at least 12 months prior to screening and on a stable ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI] or long-acting ART).
* Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
* Cluster of differentiation 4 (CD4+) T cell count >= 500 cells/µL at screening and no known evidence of CD4+ T cell count < 500 cells/µL in the last 12 months prior to screening
* Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of quantitation (LLOQ) at screening and for at least 12 months prior to screening
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug.
* History of CD4+ T cell nadir of <= 200 cells/µL during chronic HIV infection.
* History of medical disorders (other than HIV-1 infection) that, in the opinion of the investigator, might expose the participant to undue risk of harm, confound study outcomes or prevent the participant from completing the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
9/03/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Wisconsin
Country [16] 0 0
Belgium
State/province [16] 0 0
Bruxelles-Capitale
Country [17] 0 0
Belgium
State/province [17] 0 0
Oost-Vlaanderen
Country [18] 0 0
Canada
State/province [18] 0 0
British Columbia
Country [19] 0 0
Canada
State/province [19] 0 0
Ontario
Country [20] 0 0
Canada
State/province [20] 0 0
Quebec
Country [21] 0 0
Canada
State/province [21] 0 0
Saskatchewan
Country [22] 0 0
France
State/province [22] 0 0
Paris
Country [23] 0 0
Germany
State/province [23] 0 0
Nordrhein-Westfalen
Country [24] 0 0
Germany
State/province [24] 0 0
Saarland
Country [25] 0 0
Germany
State/province [25] 0 0
Berlin
Country [26] 0 0
Italy
State/province [26] 0 0
L Aquila
Country [27] 0 0
Italy
State/province [27] 0 0
Milano
Country [28] 0 0
Italy
State/province [28] 0 0
Modena
Country [29] 0 0
Japan
State/province [29] 0 0
Aichi
Country [30] 0 0
Japan
State/province [30] 0 0
Osaka
Country [31] 0 0
Japan
State/province [31] 0 0
Tokyo
Country [32] 0 0
Poland
State/province [32] 0 0
Kujawsko-pomorskie
Country [33] 0 0
Poland
State/province [33] 0 0
Pomorskie
Country [34] 0 0
Puerto Rico
State/province [34] 0 0
San Juan
Country [35] 0 0
South Africa
State/province [35] 0 0
Gauteng
Country [36] 0 0
Spain
State/province [36] 0 0
Barcelona
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
United Kingdom
State/province [38] 0 0
London, City Of

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06032546