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Human Immunodeficiency Virus (HIV)Phase 1NCT04223804

A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

A Phase 1 study testing ABBV-181 in people with Human Immunodeficiency Virus (HIV) and HIV Infection, run by AbbVie at 23 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
ABBV-181
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
23 sitesin 4 countries
Study dates
30 Jan 2020to 27 Feb 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body Mass Index (BMI) between 18.0 and 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 8 weeks prior to screening.
  • Meets HIV-specific laboratory parameters as below:
  • Plasma HIV-1 RNA below lower limit of quantification (LLOQ) 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 >= 200 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.

Who cannot join

  • Known resistance to at least 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 24 weeks prior to the first dose of study drug.
Show all 11Show fewer
  • Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.
  • Current hepatitis B virus or hepatitis C virus infection.
  • Clinically significant medical disorders that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study (including but not limited to significant or unstable cardiac, neurologic or pulmonary disease, chronic active infectious disease except for HIV, chronic liver disease, poorly controlled diabetes mellitus and history of Stevens Johnson Syndrome toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS)).
  • Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
  • Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study.

Trial locations and contacts

23 sites in 4 countries.

23 sites in 4 countries

United States15 sites

  • Franco Felizarta, Md /Id# 215721

    Bakersfield, California, 93301

  • Be Well Medical Center /ID# 223841

    Berkley, Michigan, 48072-3046

  • University of Cincinnati /ID# 215615

    Cincinnati, Ohio, 45267-0585

  • Prism Health North Texas - Oak Cliff Health Center /ID# 214036

    Dallas, Texas, 75208-4599

  • North TX Infectious Diseases /ID# 224861

    Dallas, Texas, 75246

  • Midway Immunology and Research /ID# 215587

    Ft. Pierce, Florida, 34982

  • Ruane Clinical Research Group /ID# 224866

    Los Angeles, California, 90036

  • University of Miami, Miller School of Medicine /ID# 213833

    Miami, Florida, 33136

  • Saint Michael's Medical Center /ID# 228733

    Newark, New Jersey, 07102

  • Orlando Immunology Center /ID# 243276

    Orlando, Florida, 32803

  • Mayo Clinic - Rochester /ID# 217820

    Rochester, Minnesota, 55905-0001

  • Quest Clinical Research /ID# 215796

    San Francisco, California, 94115-3037

  • Peter Shalit, M.D. /ID# 224870

    Seattle, Washington, 98104-3595

  • George Washington University Medical Faculty Associates /ID# 213893

    Washington D.C., District of Columbia, 20037-3201

  • Triple O Research Institute /ID# 224863

    West Palm Beach, Florida, 33407-3100

Other trials in United States

Australia3 sites

  • Holdsworth House Medical Practice /ID# 215352

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Sydney /ID# 215354

    Darlinghurst, New South Wales, 2010

  • The Royal Melbourne Hospital /ID# 215351

    Parkville, Victoria, 3050

Other trials in Australia

Canada3 sites

  • McGill Univ Clinical Research /ID# 218081

    Montreal, Quebec, H2X 2P4

  • Ottawa Hospital Research Institute /ID# 218083

    Ottawa, Ontario, K1H 8L6

  • Toronto General Hospital /ID# 218082

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Puerto Rico2 sites

  • Clinical Research Puerto Rico /ID# 218821

    San Juan, 00909

  • Puerto Rico AIDS Clinical Trials Unit CRS /ID# 213761

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official 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

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 Human immunodeficiency virus (HIV)-1 infected participants undergoing Antiretroviral therapy (ART) interruption.

Being tested
ABBV-181, Placebo
Keywords
Human Immunodeficiency Virus (HIV), HIV Infection, HIV-1, ABBV-181, Analytical Treatment Interruption, Budigalimab, Programmed cell death protein-1 (PD-1), Anti-PD-1 Antibody
Medical subject headings
Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-181Drug

    Also called Budigalimab

    Intravenous (IV) Infusion

  • PlaceboDrug

    Intravenous (IV) infusion

Study groups in NCT04223804
Study groupRoleWhat they receive
Stage 1: Arm APlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo
Stage 1: Arm BExperimentalParticipants will receive ABBV-181 dose A.
Receives: Drug: ABBV-181
Stage 1: Arm CExperimentalParticipants will receive ABBV-181 dose B.
Receives: Drug: ABBV-181
Stage 2: Arm DPlacebo comparatorParticipants will receive Placebo.
Receives: Drug: Placebo
Stage 2: Arm EExperimentalParticipants will receive ABBV-181 dose C.
Receives: Drug: ABBV-181

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 44 weeks

  2. 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.

    Measured: Up to approximately 44 weeks

  3. Number of Participants with Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome

    Adverse Events (AEs) Corresponding to Retroviral Rebound Syndrome.

    Measured: Up to approximately 44 weeks

  4. Maximum Observed Concentration (Cmax)

    Maximum Observed Concentration (Cmax) of ABBV-181.

    Measured: Up to approximately 36 weeks

  5. Time to Cmax (Tmax)

    Time to Cmax (Tmax) of ABBV-181.

    Measured: Up to approximately 36 weeks

  6. Observed Concentration (Ctrough)

    Observed Concentration (Ctrough) at the end of the dosing intervals for ABBV-181.

    Measured: Up to approximately 36 weeks

  7. Area Under the Curve (AUCtau)

    Area Under the Curve (AUCtau) during the dosing intervals for ABBV-181.

    Measured: Up to approximately 36 weeks

  8. Half-life (t1/2)

    Half-life (t1/2) of ABBV-181 following the last dose.

    Measured: Up to approximately 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2020
  2. Study start30 Jan 2020
  3. Primary completion27 Feb 2023
  4. Study completion27 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04223804
Sponsor's protocol ID
M19-939
Other IDs
2019-004866-16, 2019
Status last verified
Mar 2023
First submitted
8 Jan 2020
Last updated
9 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ramgopal MN, Lalezari JP, Pires Dos Santos AG, Krishnan P, Vaidya TR, Zhou F, Betman H, Dorr P, Mostafa NM, Alcaide ML, Felizarta F, Routy JP. Budigalimab, an anti-PD-1 inhibitor, for people living with HIV-1: a randomized, placebo-controlled phase 1b study. Nat Med. 2025 Nov;31(11):3879-3888. doi: 10.1038/s41591-025-03993-0. Epub 2025 Oct 15.

    PubMed 41094034

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-181 in people with Human Immunodeficiency Virus (HIV) and HIV Infection, run by AbbVie at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Australia, Canada, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Study Drug-Related Adverse Events Grade 3 or Higher (time frame: Up to approximately 44 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04223804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2023.

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