NCT06032546
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. 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). Approximately 140 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. Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 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 52 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 52 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.
Interventional study
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Please note, participation in the clinical trial is open to patients with the disease or condition under investigation. |
Age:
From 18 Years to 70 Years.
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 current ART regimen for at least 8 weeks prior to screening (current ART regimen
cannot include an Non-nucleoside reverse transcriptase inhibitor [NNRTI]).
- Negative human immuno-deficiency virus (HIV)-2 antibody (Ab)
- 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 cluster of differentiation 4 (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.
