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Human Immunodeficiency Virus (HIV)Phase 1NCT04554966

Study to Assess Adverse Events and How Intravenous (IV) or Subcutaneous (SC) ABBV-382 Moves Through the Body of Adult Participants With Human Immuno-Deficiency Virus (HIV-1)

A Phase 1 study testing ABBV-382 in people with Human Immunodeficiency Virus (HIV), run by AbbVie at 21 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. 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?
ABBV-382
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
21 sitesin 2 countries
Study dates
16 Apr 2021to 14 Aug 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) is >= 18.0 to <= 35.0 kg/m^2 after rounding to the tenths decimal.
  • Must agree to use effective barrier protection during sexual activity for protection against Human Immunodeficiency Virus (HIV)-1 transmission through the last study visit.
  • Female participants of childbearing potential must give consent to abide by contraception requirements.
  • CD4+ count of >= 350 cells/μL at screening and at least once during the 48 weeks prior to screening.
  • Negative screen for drugs of abuse and alcohol at screening. Participants with a positive marijuana screen may be included after evaluation by the investigator that the use would not interfere with adherence to study requirements, and that usage is not on a regular or chronic basis.
  • Laboratory values must meet the acceptable criteria.
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  • Part A participants must also have:
  • Positive test result for anti-HIV antibody at screening.
  • Plasma HIV-1 ribose nucleic acid (RNA) between 1,000 - 200,000 copies/mL at screening.
  • Must be naive to combination antiretroviral therapy (cART) or have been off of cART for > 12 weeks or 5 half-lives of the drug (whichever is longer) prior to screening with documentation of at least one plasma HIV-1 RNA measurement greater than or equal to the lower limit of quantification (LLOQ) during the off cART period.
  • Willing to hold on initiation of cART throughout the screening period and until 4 weeks after dosing.
  • Part B participants must also have:
  • Positive test result for anti-HIV antibody at screening.
  • Must have plasma HIV-1 RNA below the lower limit of quantification at screening and at least 24 weeks prior to screening. A single unconfirmed "blip" is allowed if preceded and followed by values below the lower limit of quantification.
  • Must be HIV-1 infected on cART for at least 48 weeks prior to screening and on current cART regimen for at least 12 weeks prior to screening.

Who cannot join

  • Female participants who are pregnant, breastfeeding, or considering becoming pregnant during the study.
  • History or ongoing diagnosis of acquired immune deficiency syndrome (AIDS)-defining illness.
  • History of or active immunodeficiency (other than HIV).
  • Active autoimmune disease or history of autoimmune disease that has required systemic treatment.
  • Clinically significant medical disorders (other than HIV-1 infection) that might expose the participant to undue risk of harm, confound study outcomes, or prevent the participant from completing the study.
  • Active or suspected malignancy or history of malignancy (other than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.
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  • History or evidence of active tuberculosis (TB) disease or untreated latent TB infection at screening.
  • No history of positive TB skin test or interferon gamma release assay (IGRA) or at screening which is considered clinically significant by the investigator. Participant with a history of a positive TB skin test or IGRA or at screening must have documentation of completion of a Centers for Disease Control and Prevention (CDC) recommended treatment course for latent TB. Any participant with suspicion for or diagnosis of active TB is excluded.
  • Known psychiatric or substance abuse disorders that would interfere with adherence to study requirements.
  • Currently enrolled in another interventional clinical study.
  • Received immunomodulatory or immunosuppressive (including intravenous [IV]/oral [PO] steroids at any dose, but excluding steroids that are inhaled or topical) therapy within 24 weeks prior to the first dose of study drug.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States19 sites

  • Central Texas Clinical Research /ID# 223378

    Austin, Texas, 78705-3326

  • Franco Felizarta, Md /Id# 223815

    Bakersfield, California, 93301

  • Be Well Medical Center /ID# 223381

    Berkley, Michigan, 48072-3046

  • The Christ Hospital /ID# 224871

    Cincinnati, Ohio, 45219

  • Prism Health North Texas - Oak Cliff Health Center /ID# 223237

    Dallas, Texas, 75208-4599

  • North Texas Infectious Diseases Consultants, P.A /ID# 223236

    Dallas, Texas, 75246

  • CenExcel iResearch LLC /ID# 225526

    Decatur, Georgia, 30030

  • Midway Immunology and Research Center /ID# 223500

    Ft. Pierce, Florida, 34982

  • The Crofoot Research Center, Inc /ID# 223383

    Houston, Texas, 77098-3900

  • University of Iowa Hospitals and Clinics /ID# 224267

    Iowa City, Iowa, 52242

  • Ruane Clinical Research Group /ID# 224125

    Los Angeles, California, 90036

  • North Shore University Hospital Manhasset /ID# 223343

    Manhasset, New York, 11030-3816

  • Infinite Clinical Trials - Morrow /ID# 225455

    Morrow, Georgia, 30260-2342

  • Orlando Immunology Center /ID# 223498

    Orlando, Florida, 32803

  • Quest Clinical Research /ID# 223347

    San Francisco, California, 94115-3037

  • Peter Shalit, M.D. /ID# 224252

    Seattle, Washington, 98104-3595

  • St. Joseph Comprehensive Research Institute /ID# 246232

    Tampa, Florida, 33614-7112

  • George Washington University Medical Faculty Associates /ID# 223493

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

  • Triple O Research Institute /ID# 223460

    West Palm Beach, Florida, 33407-3100

Other trials in United States

Puerto Rico2 sites

  • Ponce Medical School Foundation /ID# 224231

    Ponce, 00716-0377

  • Clinical Research Puerto Rico /ID# 223923

    San Juan, 00909

Other trials in Puerto Rico

About this study

Official title: A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of ABBV-382 in Persons Living With HIV-1 (PLWH)

Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV infection is considered to be a chronic disease requiring lifelong therapy. This study will evaluate how safe ABBV-382 is and how it is absorbed, distributed and eliminated from the body in adult participants with HIV-1 infection.

ABBV-382 is an investigational drug being developed for the treatment of HIV-1 infection. This study takes place in 2 parts. In Part A, participants with HIV-1 and no history of combination antiretroviral therapy (cART) or who are off cART for more than 3 months will be enrolled to receive ABBV-382. In Part B, participants with no virus in their blood and on maintenance cART will be enrolled into one of the intravenous (IV) or subcutaneous (SC) groups. In the IV groups, participants will receive either placebo or ABBV-382 whereas participants in the SC group will receive ABBV-382. There is 1 in 3 chance that participants will receive placebo (no drug) in Part B IV groups. The IV group in Part B is double-blinded which means neither the study doctors nor the participants will know who will be given study drug or placebo. Around 52 adult participants with HIV-1 infection will be enrolled at approximately 21 sites across the United States, including Puerto Rico.

Read more

Participants in Part A will receive an intravenous (IV) dose of ABBV-382 on Day 1. Participants in Part B will receive an IV or SC dose of ABBV-382 or placebo on Days 1, 29 and 57.

There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and presence of side effects.

Being tested
ABBV-382, Placebo for ABBV-382
Keywords
Human Immunodeficiency Virus, HIV, HIV-1, ABBV-382
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.

  • ABBV-382Drug

    Intravenous (IV) infusion

  • ABBV-382Drug

    Subcutaneous (SC) injection

  • Placebo for ABBV-382Drug

    Intravenous (IV) infusion

Study groups in NCT04554966
Study groupRoleWhat they receive
Part A: ABBV-382 Dose AExperimentalParticipants will receive intravenous (IV) ABBV-382 dose A on Day 1.
Receives: Drug: ABBV-382
Part A: ABBV-382 Dose BExperimentalParticipants will receive intravenous (IV) ABBV-382 dose B on Day 1.
Receives: Drug: ABBV-382
Part B: Intravenous Cohort: ABBV-382 Dose AExperimentalParticipants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.
Receives: Drug: ABBV-382
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose APlacebo comparatorParticipants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.
Receives: Drug: Placebo for ABBV-382
Part B: Intravenous Cohort: ABBV-382 Dose BExperimentalParticipants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.
Receives: Drug: ABBV-382
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose BPlacebo comparatorParticipants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.
Receives: Drug: Placebo for ABBV-382
Part B: Subcutaneous Cohort: ABBV-382ExperimentalParticipants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.
Receives: Drug: ABBV-382

What is being measured

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

  1. Incidence of 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 study drug as either "Reasonable Possibility" or "No Reasonable Possibility" and will assess the severity of each adverse event from Grade 1 (mild) to Grade 4 (potentially life-threatening).

    Measured: Up to Day 255

  2. Maximum Observed Serum Concentration (Cmax) of ABBV-382 (Part A and Part B)

    Maximum observed serum concentration (Cmax) of ABBV-382.

    Measured: Up to Day 225

  3. Time to Cmax (Tmax) of ABBV-382 (Part A and Part B)

    Time to Cmax (Tmax) of ABBV-382.

    Measured: Up to Day 225

  4. Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A)

    Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.

    Measured: Up to Day 112

  5. Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A)

    AUC from time 0 to infinite time (AUCinf) of ABBV-382.

    Measured: Up to Day 112

  6. Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A)

    Terminal phase elimination rate constant of ABBV-382.

    Measured: Up to Day 112

  7. Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A)

    Terminal phase elimination half-life of ABBV-382.

    Measured: Up to Day 112

  8. Observed Concentration at the End of the 4-Week Dosing Interval (Ctrough) of ABBV-382 (Part B)

    Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382.

    Measured: Up to Day 225

  9. AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)

    AUC during the 4-week dosing interval (AUCtau) of ABBV-382.

    Measured: Up to Day 225

  10. Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part B)

    Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.

    Measured: Day 57 to Day 225

Timeline

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

  1. First posted18 Sep 2020
  2. Study start16 Apr 2021
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 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
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04554966
Sponsor's protocol ID
M19-966
Status last verified
Mar 2024
First submitted
14 Sep 2020
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ABBV-382 in people with Human Immunodeficiency Virus (HIV), run by AbbVie at 21 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 15 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 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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. 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?

Incidence of Study Drug-Related Grade 3 or Higher Adverse Events (AEs) (time frame: Up to Day 255). The study lists 10 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 NCT04554966.

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 4 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.

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