search
Back to results

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)

Primary Purpose

Human Immunodeficiency Virus (HIV)

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABBV-382
ABBV-382
Placebo for ABBV-382
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus (HIV) focused on measuring Human Immunodeficiency Virus, HIV, HIV-1, ABBV-382

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

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.

Exclusion Criteria:

  • 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.
  • 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.

Sites / Locations

  • Franco Felizarta, Md /Id# 223815
  • Ruane Clinical Research Group /ID# 224125
  • Quest Clinical Research /ID# 223347
  • George Washington University Medical Faculty Associates /ID# 223493
  • Midway Immunology and Research Center /ID# 223500
  • Orlando Immunology Center /ID# 223498
  • St. Joseph Comprehensive Research Institute /ID# 246232
  • Triple O Research Institute /ID# 223460
  • CenExcel iResearch LLC /ID# 225526
  • Infinite Clinical Trials - Morrow /ID# 225455
  • University of Iowa Hospitals and Clinics /ID# 224267
  • Be Well Medical Center /ID# 223381
  • North Shore University Hospital Manhasset /ID# 223343
  • The Christ Hospital /ID# 224871
  • Central Texas Clinical Research /ID# 223378
  • Prism Health North Texas - Oak Cliff Health Center /ID# 223237
  • North Texas Infectious Diseases Consultants, P.A /ID# 223236
  • The Crofoot Research Center, Inc /ID# 223383
  • Peter Shalit, M.D. /ID# 224252
  • Ponce Medical School Foundation /ID# 224231
  • Clinical Research Puerto Rico /ID# 223923

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

Part A: ABBV-382 Dose A

Part A: ABBV-382 Dose B

Part B: Intravenous Cohort: ABBV-382 Dose A

Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A

Part B: Intravenous Cohort: ABBV-382 Dose B

Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B

Part B: Subcutaneous Cohort: ABBV-382

Arm Description

Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.

Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.

Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.

Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.

Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.

Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.

Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.

Outcomes

Primary Outcome Measures

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).
Maximum Observed Serum Concentration (Cmax) of ABBV-382 (Part A and Part B)
Maximum observed serum concentration (Cmax) of ABBV-382.
Time to Cmax (Tmax) of ABBV-382 (Part A and Part B)
Time to Cmax (Tmax) of ABBV-382.
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.
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.
Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A)
Terminal phase elimination rate constant of ABBV-382.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A)
Terminal phase elimination half-life of ABBV-382.
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.
AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)
AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2020
Last Updated
August 24, 2023
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT04554966
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
April 16, 2021 (Actual)
Primary Completion Date
August 2, 2023 (Actual)
Study Completion Date
August 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Human Immunodeficiency Virus, HIV, HIV-1, ABBV-382

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: ABBV-382 Dose A
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.
Arm Title
Part A: ABBV-382 Dose B
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.
Arm Title
Part B: Intravenous Cohort: ABBV-382 Dose A
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.
Arm Title
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A
Arm Type
Placebo Comparator
Arm Description
Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.
Arm Title
Part B: Intravenous Cohort: ABBV-382 Dose B
Arm Type
Experimental
Arm Description
Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.
Arm Title
Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B
Arm Type
Placebo Comparator
Arm Description
Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.
Arm Title
Part B: Subcutaneous Cohort: ABBV-382
Arm Type
Experimental
Arm Description
Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.
Intervention Type
Drug
Intervention Name(s)
ABBV-382
Intervention Description
Intravenous (IV) infusion
Intervention Type
Drug
Intervention Name(s)
ABBV-382
Intervention Description
Subcutaneous (SC) injection
Intervention Type
Drug
Intervention Name(s)
Placebo for ABBV-382
Intervention Description
Intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Incidence of Study Drug-Related Grade 3 or Higher Adverse Events (AEs)
Description
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).
Time Frame
Up to Day 255
Title
Maximum Observed Serum Concentration (Cmax) of ABBV-382 (Part A and Part B)
Description
Maximum observed serum concentration (Cmax) of ABBV-382.
Time Frame
Up to Day 225
Title
Time to Cmax (Tmax) of ABBV-382 (Part A and Part B)
Description
Time to Cmax (Tmax) of ABBV-382.
Time Frame
Up to Day 225
Title
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382 (Part A)
Description
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
Time Frame
Up to Day 112
Title
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382 (Part A)
Description
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Time Frame
Up to Day 112
Title
Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A)
Description
Terminal phase elimination rate constant of ABBV-382.
Time Frame
Up to Day 112
Title
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A)
Description
Terminal phase elimination half-life of ABBV-382.
Time Frame
Up to Day 112
Title
Observed Concentration at the End of the 4-Week Dosing Interval (Ctrough) of ABBV-382 (Part B)
Description
Observed concentration at the end of the 4-week dosing interval (Ctrough) of ABBV-382.
Time Frame
Up to Day 225
Title
AUC During the 4-Week Dosing Interval (AUCtau) of ABBV-382 (Part B)
Description
AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
Time Frame
Up to Day 225
Title
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part B)
Description
Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.
Time Frame
Day 57 to Day 225

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Franco Felizarta, Md /Id# 223815
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Ruane Clinical Research Group /ID# 224125
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Quest Clinical Research /ID# 223347
City
San Francisco
State/Province
California
ZIP/Postal Code
94115-3037
Country
United States
Facility Name
George Washington University Medical Faculty Associates /ID# 223493
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-3201
Country
United States
Facility Name
Midway Immunology and Research Center /ID# 223500
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34982
Country
United States
Facility Name
Orlando Immunology Center /ID# 223498
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
St. Joseph Comprehensive Research Institute /ID# 246232
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614-7112
Country
United States
Facility Name
Triple O Research Institute /ID# 223460
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3100
Country
United States
Facility Name
CenExcel iResearch LLC /ID# 225526
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Infinite Clinical Trials - Morrow /ID# 225455
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260-2342
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 224267
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Be Well Medical Center /ID# 223381
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072-3046
Country
United States
Facility Name
North Shore University Hospital Manhasset /ID# 223343
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030-3816
Country
United States
Facility Name
The Christ Hospital /ID# 224871
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Central Texas Clinical Research /ID# 223378
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-3326
Country
United States
Facility Name
Prism Health North Texas - Oak Cliff Health Center /ID# 223237
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208-4599
Country
United States
Facility Name
North Texas Infectious Diseases Consultants, P.A /ID# 223236
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The Crofoot Research Center, Inc /ID# 223383
City
Houston
State/Province
Texas
ZIP/Postal Code
77098-3900
Country
United States
Facility Name
Peter Shalit, M.D. /ID# 224252
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-3595
Country
United States
Facility Name
Ponce Medical School Foundation /ID# 224231
City
Ponce
ZIP/Postal Code
00716-0377
Country
Puerto Rico
Facility Name
Clinical Research Puerto Rico /ID# 223923
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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)

We'll reach out to this number within 24 hrs