Human Immuno-deficiency Virus (HIV) Disease
Conditions
Keywords
Human immuno-deficiency virus (HIV) Disease, Budigalimab, ABBV-382
Brief summary
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. In Part 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). In Part 2, eligible participants will be placed in an open-label arm to receive Budigalimab. Approximately 160 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. In Part 1, participants will receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. In Part 2, participants will receive 4 doses of open-label subcutaneous (SC) Budigalimab for a 6 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 112 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 112 weeks. There may be 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. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGBudigalimab
Intravenous (IV) Infusion
DRUGPlacebo for Budigalimab
IV Infusion
DRUGABBV-382
IV Infusion
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* A condition of general good health in the opinion of the investigator, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). * Must be on antiretroviral therapy (ART) for at least 12 months prior to screening and on a stable ART regimen for at least 8 weeks prior to screening (current ART regimen cannot include an Non-nucleoside reverse transcriptase inhibitor \[NNRTI\] or long-acting ART). * Negative human immuno-deficiency virus (HIV)-2 antibody (Ab) * Cluster of differentiation 4 (CD4+) T cell count \>= 500 cells/μL at screening and no known evidence of CD4+ T cell count \< 500 cells/μL in the last 12 months prior to screening * Participant must have plasma HIV-1 ribonucleic acid (RNA) below the lower limit of quantitation (LLOQ) at screening and for at least 12 months prior to screening
Exclusion criteria
* Prior exposure to long acting antiretrovirals within 24 weeks or within a period defined by 5 half-lives, whichever is longer, prior to randomization and prior to the first dose of study drug. * History of CD4+ T cell nadir of \<= 200 cells/μL during chronic HIV infection. * History of medical disorders (other than HIV-1 infection) that, in the opinion of the investigator, might expose the participant to undue risk of harm, confound study outcomes or prevent the participant from completing the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Viral Control Without Antiretroviral Therapy (ART) Restart | Week 24 | Percentage of participants who achieve viral control (viral load \< 1000 copies/mL) without ART restart at Week 24. |
| Number of Participants with Adverse Events (AEs) | Up to approximately Week 112 | An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Peak Viral Load (At Rebound) Prior to Re-Starting ART | Up to 112 weeks | The median peak viral load (at rebound) before re-starting ART. |
| Median Time to First Rebound to >= 1000 Copies/mL During ART Interruption | Up to 112 weeks | The median time to rebound to \>= 1000 copies/mL during ART interruption. |
Countries
Belgium, Brazil, Canada, France, Germany, Italy, Japan, Poland, Puerto Rico, South Africa, Spain, United Kingdom, United States
Outcome results
None listed