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)
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| ClinicalTrials.gov Identifier: NCT04554966 |
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Recruitment Status :
Completed
First Posted : September 18, 2020
Last Update Posted : March 4, 2024
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Human Immunodeficiency Virus (HIV) | Drug: ABBV-382 Drug: Placebo for ABBV-382 | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 54 participants |
| Allocation: | Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | April 16, 2021 |
| Actual Primary Completion Date : | August 14, 2023 |
| Actual Study Completion Date : | August 14, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part A: ABBV-382 Dose A
Participants will receive intravenous (IV) ABBV-382 dose A on Day 1.
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Drug: ABBV-382
Intravenous (IV) infusion |
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Experimental: Part A: ABBV-382 Dose B
Participants will receive intravenous (IV) ABBV-382 dose B on Day 1.
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Drug: ABBV-382
Intravenous (IV) infusion |
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Experimental: Part B: Intravenous Cohort: ABBV-382 Dose A
Participants will receive intravenous (IV) ABBV-382 dose A on Days 1, 29 and 57.
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Drug: ABBV-382
Intravenous (IV) infusion |
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Placebo Comparator: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose A
Participants will receive intravenous (IV) placebo for ABBV-382 dose A on Days 1, 29 and 57.
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Drug: Placebo for ABBV-382
Intravenous (IV) infusion |
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Experimental: Part B: Intravenous Cohort: ABBV-382 Dose B
Participants will receive intravenous (IV) ABBV-382 dose B on Days 1, 29 and 57.
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Drug: ABBV-382
Intravenous (IV) infusion |
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Placebo Comparator: Part B: Intravenous Cohort: Placebo for ABBV-382 Dose B
Participants will receive intravenous (IV) placebo for ABBV-382 dose B on Days 1, 29 and 57.
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Drug: Placebo for ABBV-382
Intravenous (IV) infusion |
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Experimental: Part B: Subcutaneous Cohort: ABBV-382
Participants will receive subcutaneous (SC) ABBV-382 dose C on Days 1, 29 and 57.
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Drug: ABBV-382
Subcutaneous (SC) injection |
- Incidence of Study Drug-Related Grade 3 or Higher Adverse Events (AEs) [ Time Frame: Up to Day 255 ]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) [ Time Frame: Up to Day 225 ]Maximum observed serum concentration (Cmax) of ABBV-382.
- Time to Cmax (Tmax) of ABBV-382 (Part A and Part B) [ Time Frame: Up to Day 225 ]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) [ Time Frame: Up to Day 112 ]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) [ Time Frame: Up to Day 112 ]AUC from time 0 to infinite time (AUCinf) of ABBV-382.
- Terminal Phase Elimination Rate Constant (β) of ABBV-382 (Part A) [ Time Frame: Up to Day 112 ]Terminal phase elimination rate constant of ABBV-382.
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part A) [ Time Frame: Up to Day 112 ]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) [ Time Frame: Up to Day 225 ]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) [ Time Frame: Up to Day 225 ]AUC during the 4-week dosing interval (AUCtau) of ABBV-382.
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-382 (Part B) [ Time Frame: Day 57 to Day 225 ]Terminal phase elimination half-life (t1/2) of ABBV-382 will be estimated after the third dose only.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04554966
Show 21 study locations
| Study Director: | ABBVIE INC. | AbbVie |
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT04554966 |
| Other Study ID Numbers: |
M19-966 |
| First Posted: | September 18, 2020 Key Record Dates |
| Last Update Posted: | March 4, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
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Human Immunodeficiency Virus HIV HIV-1 ABBV-382 |
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Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases 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 |