Human Immunodeficiency Virus (HIV)Phase 1NCT04799353
Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)
A Phase 1 study testing Budigalimab in people with Human Immunodeficiency Virus (HIV), run by AbbVie at 10 sites in 2 countries.
Trial summary
This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection. Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Human Immunodeficiency Virus (HIV)
- What is being tested?
- Budigalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 15 Mar 2021to 11 Oct 2022
- 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
- Condition of generally good health, body mass index ≥ 18.0 to < 35.0 kg/m2.
- Laboratory values must meet acceptable criteria.
- Human Immunodeficiency Virus (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.
- CD4 cell count ≥ 450 cells/μL at Screening and during the 12 months prior to Screening.
- Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.
- Participants agreeing to use an effective barrier method of protection (male and/or female condom) during sexual activity from Study Day 1 through last study visit for the purposes of prevention of HIV transmission.
Who cannot join
- Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.
- Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.
- Participants having history of or active immunodeficiency (other than HIV).
- Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.
- Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4].
- Participants having clinically significant medical disorders that might expose the subjects to undue risk of harm, confound study outcomes, or prevent the subject from completing the study.
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- Participants having active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
- Participants with history of or active tuberculosis (TB) at screening.
- Participants having known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
- Participants who have received immunomodulatory or immunosuppressive (including IV/orally administered [PO] steroids at any dose, but excluding steroids that are inhaled, topical or via local injection) therapy within 24 weeks prior to the first dose of study drug.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States8 sites
Central Texas Clinical Research /ID# 223937
Austin, Texas, 78705-3326
Franco Felizarta, Md /Id# 223931
Bakersfield, California, 93301
St. Hope Foundation, Inc. /ID# 224492
Bellaire, Texas, 77401-4528
North TX Infectious Diseases /ID# 224494
Dallas, Texas, 75246
The Crofoot Research Center, Inc /ID# 224493
Houston, Texas, 77098-3900
Ruane Clinical Research Group /ID# 224496
Los Angeles, California, 90036
Quest Clinical Research /ID# 223925
San Francisco, California, 94115-3037
Peter Shalit, M.D. /ID# 224801
Seattle, Washington, 98104-3595
Puerto Rico2 sites
Ponce Medical School Foundation /ID# 224230
Ponce, 00716-0377
Puerto Rico AIDS Clinical Trials Unit CRS /ID# 223936
San Juan, 00935
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)
This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.
Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.
Read more
Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks.
Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
- Conditions
- Human Immunodeficiency Virus (HIV)
- Being tested
- Budigalimab, Placebo
- Keywords
- Human Immunodeficiency Virus (HIV), Budigalimab, ABBV-181
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudigalimabDrug
Also called ABBV-181
Subcutaneous (SC)
PlaceboDrug
Subcutaneous (SC)
BudigalimabDrug
Also called ABBV-181
Intravenous (IV)
PlaceboDrug
Intravenous (IV)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Placebo SC + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo. Receives: Drug: Placebo |
| Group 2: Budigalimab (SC) + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. Receives: Drug: Budigalimab; Drug: Placebo |
| Group 3: Budigalimab SC + Placebo IV | Experimental | Participants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. Receives: Drug: Budigalimab; Drug: Placebo |
| Group 4: Placebo SC + Budigalimab IV | Experimental | Participants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab. Receives: Drug: Placebo; Drug: Budigalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
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 24 weeks
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 National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Measured: Up to approximately 24 weeks
Maximum Serum Concentration (Cmax)
Maximum Serum Concentration (Cmax) of Budigalimab.
Measured: Up to approximately 24 weeks
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Measured: Up to approximately 24 weeks
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Area Under the Plasma Concentration-time Curve (AUC).
Measured: Up to approximately 24 weeks
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
Terminal phase elimination half-life (t1/2)
Measured: Up to approximately 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start15 Mar 2021
- Primary completion11 Oct 2022
- Study completion11 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799353
- Sponsor's protocol ID
- M19-972
- Status last verified
- Oct 2022
- First submitted
- 12 Mar 2021
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled Single-Dose Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous and Intravenous Administration of Budigalimab in Adult People Living With HIV-1 (PLWH)
- ClinicalTrials.gov ID
- NCT04799353
- Acronym / sponsor ID
- M19-972
- Conditions
- Human Immunodeficiency Virus (HIV)
- Keywords
- Human Immunodeficiency Virus (HIV), Budigalimab, ABBV-181
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 11 Oct 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 16 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection.
Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide.
Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks.
Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Placebo SC + Placebo IV | Experimental | Drug: PlaceboParticipants will receive Subcutaneous (SC) Placebo, followed by Intravenous (IV) Placebo. |
| Group 2: Budigalimab (SC) + Placebo IV | Experimental | Drug: Budigalimab, Drug: PlaceboParticipants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 3: Budigalimab SC + Placebo IV | Experimental | Drug: Budigalimab, Drug: PlaceboParticipants will receive Subcutaneous (SC) Budigalimab, followed by Intravenous (IV) Placebo. |
| Group 4: Placebo SC + Budigalimab IV | Experimental | Drug: Placebo, Drug: BudigalimabParticipants will receive Subcutaneous (SC) Placebo, followed by IV Budigalimab. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Condition of generally good health, body mass index ≥ 18.0 to < 35.0 kg/m2.
- Laboratory values must meet acceptable criteria.
- Human Immunodeficiency Virus (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.
- CD4 cell count ≥ 450 cells/μL at Screening and during the 12 months prior to Screening.
- Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6 months prior to Screening.
Key exclusion criteria (10 listed)
- Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to the Day 1 dose.
- Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome (AIDS)-defining illness.
- Participants having history of or active immunodeficiency (other than HIV).
- Participants having active autoimmune disease or history of autoimmune disease that has required systemic treatment.
- Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor [e.g., anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4].
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudigalimabAlso: ABBV-181Subcutaneous (SC) | Drug | Group 2: Budigalimab (SC) + Placebo IV, Group 3: Budigalimab SC + Placebo IV |
| PlaceboSubcutaneous (SC) | Drug | Group 1: Placebo SC + Placebo IV, Group 4: Placebo SC + Budigalimab IV |
| BudigalimabAlso: ABBV-181Intravenous (IV) | Drug | Group 4: Placebo SC + Budigalimab IV |
| PlaceboIntravenous (IV) | Drug | Group 1: Placebo SC + Placebo IV, Group 2: Budigalimab (SC) + Placebo IV, Group 3: Budigalimab SC + Placebo IV |
Primary outcome
Number of Participants Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
Time frame: Up to approximately 24 weeks
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.
Number of Participants With Study Drug-Related Immune-Related Adverse Events (IRAE)
Time frame: Up to approximately 24 weeks
Assessed using the American Society of Clinical Oncology (ASCO) IRAE management guidelines [which utilizes the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) grading scale] but modified, as applicable, according to the NIH Division of AIDS (DAIDS) (v2.1) AE grading scale.
Maximum Serum Concentration (Cmax)
Time frame: Up to approximately 24 weeks
Maximum Serum Concentration (Cmax) of Budigalimab.
Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to approximately 24 weeks
Time to Maximum Observed Plasma Concentration (Tmax) of Budigalimab.
Area Under the Plasma Concentration-time Curve (AUC) of Budigalimab in Plasma
Time frame: Up to approximately 24 weeks
Area Under the Plasma Concentration-time Curve (AUC).
Terminal Phase Elimination Half-life (t1/2) of Budigalimab in Plasma
Time frame: Up to approximately 24 weeks.
Terminal phase elimination half-life (t1/2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Budigalimab in people with Human Immunodeficiency Virus (HIV), run by AbbVie at 10 sites in 2 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 6 inclusion and 10 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 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, 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. 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 Experiencing Study Drug-Related Grade 3 or Higher Adverse Events (AEs) (time frame: Up to approximately 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2022.