Overview

Study to Evaluate the Safety and How the Body Handles a Single Dose of Subcutaneous (SC) and Intravenous (IV) Budigalimab in Adult Participants Living With Human Immunodeficiency Virus (HIV)

Status:
Recruiting
Trial end date:
2022-10-02
Target enrollment:
0
Participant gender:
All
Summary
This study will evaluate how safe Budigalimab is and how it moves within the body in adult participants with HIV-1 infection. Budigalimab is an investigational drug being evaluated for the treatment of Human Immunodeficiency Virus. Study participants will be assigned to one of the 4 treatment groups and will receive a single dose of Budigalimab or placebo subcutaneous (SC) and intravenous (IV). Around 32 participants 18-65 years of age living with Human Immunodeficiency Virus will be enrolled in the study in approximately 9 sites worldwide. Each participant will receive single dose of SC and IV Budigalimab and/or Placebo on day 1 and will be followed for 24 weeks. Participants will attend weekly to every two and every four weeks visits during the study at a hospital. The effect of the treatment will be checked by medical assessments, blood tests and checking for side effects. There may be higher treatment burden for participants in this trial.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AbbVie
Criteria
Inclusion Criteria:

- Condition of generally good health, body mass index ≥ 18.0 to < 35.0 kg/m2.

- Laboratory values must meet acceptable criteria.

- Human Immunodeficiency Virus (HIV-1) infected 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.

- CD4 cell count ≥ 450 cells/μL at Screening and during the 12 months prior to
Screening.

- Plasma HIV-1 RNA below the lower limit of quantification at Screening and at least 6
months prior to Screening.

- Participants agreeing to use an effective barrier method of protection (male and/or
female condom) during sexual activity from Study Day 1 through last study visit for
the purposes of prevention of HIV transmission.

Exclusion Criteria:

- Participants with signs/symptoms associated with SARS-CoV-2 infection OR Current
SARS-CoV-2 infection by any viral nucleic acid test completed within 7 days prior to
the Day 1 dose.

- Participants having history or ongoing diagnosis of acquired immunodeficiency syndrome
(AIDS)-defining illness.

- Participants having history of or active immunodeficiency (other than HIV).

- Participants having active autoimmune disease or history of autoimmune disease that
has required systemic treatment.

- Prior therapy/exposure to budigalimab or any other immune checkpoint inhibitor [e.g.,
anti-programmed cell death protein 1(PD-1), anti-PD-L1, anti-PD-L2, anti-CTLA4].

- Participants having clinically significant medical disorders that might expose the
subjects to undue risk of harm, confound study outcomes, or prevent the subject from
completing the study.

- Participants having active or suspected malignancy or history of malignancy (other
than basal cell skin cancer or cervical carcinoma in situ) in the past 5 years.

- Participants with history of or active tuberculosis (TB) at screening.

- Participants having known psychiatric or substance abuse disorders that would
interfere with adherence to study requirements.

- Participants who have received immunomodulatory or immunosuppressive (including
IV/orally administered [PO] steroids at any dose, but excluding steroids that are
inhaled, topical or via local injection) therapy within 24 weeks prior to the first
dose of study drug.