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)

NCT04554966 | Completed Phase 1 FDA Drug

• 1 other identifier: M19-966
• Study Type: interventional
• Target: 54
• Locations: 2 countries
• Sites: 21

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.

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Human Immunodeficiency Virus; HIV; HIV-1; ABBV-382

Outcome Measures

Primary Outcomes (10)

• 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).

  Up to Day 255

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

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

  Up to Day 225

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

  Time to Cmax (Tmax) of ABBV-382.

  Up to Day 225

• 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.

  Up to Day 112

• 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.

  Up to Day 112

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

  Terminal phase elimination rate constant of ABBV-382.

  Up to Day 112

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

  Terminal phase elimination half-life of ABBV-382.

  Up to Day 112

• 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.

  Up to Day 225

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

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

  Up to Day 225

• 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.

  Day 57 to Day 225

Study Arms (7)

Part A: ABBV-382 Dose A

EXPERIMENTAL

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

Drug: ABBV-382

Part A: ABBV-382 Dose B

EXPERIMENTAL

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

Drug: ABBV-382

Part B: Intravenous Cohort: ABBV-382 Dose A

EXPERIMENTAL

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

Drug: ABBV-382

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

PLACEBO COMPARATOR

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

Drug: Placebo for ABBV-382

Part B: Intravenous Cohort: ABBV-382 Dose B

EXPERIMENTAL

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

Drug: ABBV-382

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

PLACEBO COMPARATOR

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

Drug: Placebo for ABBV-382

Part B: Subcutaneous Cohort: ABBV-382

EXPERIMENTAL

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

Drug: ABBV-382

Interventions

ABBV-382 DRUG

Intravenous (IV) infusion

Part A: ABBV-382 Dose A; Part A: ABBV-382 Dose B; Part B: Intravenous Cohort: ABBV-382 Dose A; Part B: Intravenous Cohort: ABBV-382 Dose B

Placebo for ABBV-382 DRUG

Intravenous (IV) infusion

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (21)

Franco Felizarta, Md /Id# 223815

Bakersfield, California, 93301, United States

Location

Ruane Clinical Research Group /ID# 224125

Los Angeles, California, 90036, United States

Location

Quest Clinical Research /ID# 223347

San Francisco, California, 94115-3037, United States

Location

George Washington University Medical Faculty Associates /ID# 223493

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

Location

Midway Immunology and Research Center /ID# 223500

Ft. Pierce, Florida, 34982, United States

Location

Orlando Immunology Center /ID# 223498

Orlando, Florida, 32803, United States

Location

St. Joseph Comprehensive Research Institute /ID# 246232

Tampa, Florida, 33614-7112, United States

Location

Triple O Research Institute /ID# 223460

West Palm Beach, Florida, 33407-3100, United States

Location

CenExcel iResearch LLC /ID# 225526

Decatur, Georgia, 30030, United States

Location

Infinite Clinical Trials - Morrow /ID# 225455

Morrow, Georgia, 30260-2342, United States

Location

University of Iowa Hospitals and Clinics /ID# 224267

Iowa City, Iowa, 52242, United States

Location

Be Well Medical Center /ID# 223381

Berkley, Michigan, 48072-3046, United States

Location

North Shore University Hospital Manhasset /ID# 223343

Manhasset, New York, 11030-3816, United States

Location

The Christ Hospital /ID# 224871

Cincinnati, Ohio, 45219, United States

Location

Central Texas Clinical Research /ID# 223378

Austin, Texas, 78705-3326, United States

Location

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

Dallas, Texas, 75208-4599, United States

Location

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

Dallas, Texas, 75246, United States

Location

The Crofoot Research Center, Inc /ID# 223383

Houston, Texas, 77098-3900, United States

Location

Peter Shalit, M.D. /ID# 224252

Seattle, Washington, 98104-3595, United States

Location

Ponce Medical School Foundation /ID# 224231

Ponce, 00716-0377, Puerto Rico

Location

Clinical Research Puerto Rico /ID# 223923

San Juan, 00909, Puerto Rico

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: April 16, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); PR (2)