A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With Human Immunodeficiency Virus (HIV)-1

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AbbVie

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called ABBV-181 in people with HIV who are stopping their usual treatment. The goal is to see if the drug is safe and effective, and how it affects the immune system and the virus.

Eligibility Criteria

Inclusion Criteria

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.

Meets HIV-specific laboratory parameters as below: Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at screening and at least 6 months prior to screening. CD4+ T cell count >= 500 cells/uL at screening and at least once during the 12 months prior to screening. CD4+ T cell nadir of >= 200 cells/uL during chronic infection. Willing to undergo ART interruption. Agrees to use an effective barrier method of protection (male and/or female condoms) during sexual activity for protection against HIV-1 transmission throughout the entire study.

Your body mass index (BMI) falls between 18 and 35, which is considered a healthy weight range for your height.

Exclusion Criteria

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

Prior receipt of immunomodulatory or immunosuppressive (including intravenous infusion or oral steroids at any dose, but excluding steroids that are inhaled, topical or by local injection) therapy within 24 weeks prior to the first dose of study drug.

Prior therapy/exposure to ABBV-181 or any other immune checkpoint inhibitor.

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