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HIV: Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy
EU CTIS ID: 2023-505900-53-00
What this study is testing
To evaluate efficacy, safety, tolerability, and PK of budigalimab and/or ABBV-382 versus placebo in PLWH on stable ART undergoing ATI.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- PLWH between 18-70 years old, in general good health and on ART for at least 12 months prior to screening and on current ART regimen for at least 8 weeks prior to screening.
- Participants must have negative HIV-2 Ab at screening; plasma HIV-1 RNA below LLOQ at screening and for at least 12 months prior to screening; and 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.
You likely can't join if
- Participants that have had 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.
- Participants have known history of CD4+ T cell nadir of ≤ 200 cells/μL during chronic HIV infection.
- Participants with clinically significant medical disorders per investigator's assessment that might expose the participants to undue risk of harm, confound study outcomes, or prevent the participant from completing the study.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- South Africa
- United Kingdom
- United States
- Brazil
- Japan
- Puerto Rico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; South Africa; United Kingdom; United States; Brazil; Japan and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.