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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04223804




Registration number
NCT04223804
Ethics application status
Date submitted
8/01/2020
Date registered
10/01/2020
Date last updated
5/05/2020

Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With HIV-1
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of ABBV-181 in HIV-1 Infected Adults
Secondary ID [1] 0 0
2019-004866-16
Secondary ID [2] 0 0
M19-939
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Immunodeficiency Virus (HIV) 0 0
HIV Infection 0 0
HIV-1 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 - ABBV-181
Treatment: Drugs - Placebo

Experimental: Stage 2: Arm F - Participants will receive ABBV-181 dose D

Experimental: Stage 2: Arm E - Participants will receive ABBV-181 dose C

Placebo Comparator: Stage 2: Arm D - Participants will receive Placebo

Experimental: Stage 1: Arm C - Participants will receive ABBV-181 dose B

Experimental: Stage 1: Arm B - Participants will receive ABBV-181 dose A

Placebo Comparator: Stage 1: Arm A - Participants will receive placebo


Treatment: Drugs: ABBV-181
Intravenous (IV) infusion

Treatment: Drugs: Placebo
Intravenous (IV) infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher - An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of the study drug as either having a reasonable possibility or no reasonable possibility. AEs are given a grade from 1-5 with Grade 3 being severe but not life-threatening and requiring hospitalization, Grade 4 being life-threatening requiring immediate intervention and Grade 5 being death related to an AE.
Timepoint [1] 0 0
Up to approximately 44 weeks
Primary outcome [2] 0 0
Number of Participants with Study Drug-Related Immune-Related Adverse Events (IRAE) - Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines (which utilizes the NIH CTCAE grading scale) but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Timepoint [2] 0 0
Up to approximately 44 weeks
Primary outcome [3] 0 0
Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome - Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome
Timepoint [3] 0 0
Up to approximately 44 weeks
Primary outcome [4] 0 0
Maximum Observed Concentration (Cmax) - Maximum Observed Concentration (Cmax) of ABBV-181
Timepoint [4] 0 0
Up to approximately 28 weeks
Primary outcome [5] 0 0
Time to Cmax (Tmax) - Time to Cmax (Tmax) of ABBV-181
Timepoint [5] 0 0
Up to approximately 28 weeks
Primary outcome [6] 0 0
Observed Concentration (Ctrough) - Observed Concentration (Ctrough) at the end of the 4-week dosing interval for ABBV-181.
Timepoint [6] 0 0
Up to approximately 28 weeks
Primary outcome [7] 0 0
Area Under the Curve (AUCtau) - Area Under the Curve (AUCtau) during the 4-week dosing interval for ABBV-181.
Timepoint [7] 0 0
Up to approximately 28 weeks
Primary outcome [8] 0 0
Half-life (t1/2) - Half-life (t1/2) of ABBV-181 for the second dose.
Timepoint [8] 0 0
Up to approximately 28 weeks
Secondary outcome [1] 0 0
Peripheral PD-1 Receptor Saturation - Peripheral PD-1 Receptor Saturation on CD4+ and CD8+ T cell subsets.
Timepoint [1] 0 0
Up to approximately 28 weeks

Eligibility
Key inclusion criteria
- Body Mass Index (BMI) >= 18.0 to <35 kg/m2

- HIV-1 infected on antiretroviral therapy (ART) for at least 12 months prior to
screening and on current ART regimen for at least 12 weeks prior to screening.

- Meets HIV-specific laboratory parameters as below:

- Plasma HIV-1 RNA below lower limit of detection (LLOD) at screening and at least
6 months prior to screening

- CD4+ T cell count >= 500 cells/uL at screening and at least once during the 12
months prior to screening

- CD4+ T cell nadir of >= 350 cells/uL during chronic infection

- Willing to undergo ART interruption

- Agrees to use an effective barrier method of protection (male and/or female condoms)
during sexual activity for protection against HIV-1 transmission throughout the entire
study
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Known resistance to >= 2 classes of ART

- History of AIDS-defining illness

- Active or suspected malignancy or history of malignancy (other than basal cell skin
cancer or cervical carcinoma in situ) in the past 5 years

- History of or active immunodeficiency (other than HIV)

- Active autoimmune disease or history of autoimmune disease that has required systemic
treatment

- Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion
or oral steroids at any dose, but excluding steroids that are inhaled, topical or by
local injection) therapy within 6 months prior to the first dose of study drug

- Current hepatitis B virus or hepatitis C virus infection

- Female participants must not be pregnant, breastfeeding, or considering becoming
pregnant during 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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital, Darlinghurst /ID# 215354 - Darlinghurst
Recruitment hospital [2] 0 0
Holdsworth House Medical Practice /ID# 215352 - Sydney
Recruitment hospital [3] 0 0
Royal Adelaide Hospital /ID# 217077 - Adelaide
Recruitment hospital [4] 0 0
Royal Melbourne Hospital /ID# 215351 - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3050 - Parkville
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
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
Canada
State/province [9] 0 0
Ontario
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec
Country [11] 0 0
France
State/province [11] 0 0
Paris
Country [12] 0 0
Puerto Rico
State/province [12] 0 0
San Juan

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

Ethics approval
Ethics application status

Summary
Brief summary
This study will be conducted in two stages and will test the safety/tolerability,
pharmacokinetics (how the body handles study drug) and pharmacodynamics (effects on the
immune system and the virus) of the study drug ABBV-181 in HIV-1 infected participants
undergoing ART interruption.
Trial website
https://clinicaltrials.gov/show/NCT04223804
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
847.283.8955
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04223804