Budigalimab + ABBV-382 for HIV/AIDS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing two new drugs, Budigalimab and ABBV-382, to treat HIV. It involves adults with stable HIV who will pause their usual treatment. The goal is to see if these new drugs can control the virus better.
Do I have to stop taking my current medications for this trial?
Yes, you will need to stop your antiretroviral medications for 112 weeks or until specific criteria are met to restart them. This is called an analytical treatment interruption (ATI).
Will I have to stop taking my current medications?
Yes, participants will need to stop their antiretroviral medications for 112 weeks or until they meet specific criteria to restart them. This is part of the study's analytical treatment interruption (ATI) process.
What safety data is available for Budigalimab + ABBV-382 in HIV/AIDS treatment?
The provided research does not contain specific safety data for Budigalimab + ABBV-382 or its other names (ABBV-382, ABBV 1882, Budigalimab, ABBV-181). The studies mentioned focus on other antiretroviral drugs and treatments, such as lopinavir/ritonavir, telbivudine, nevirapine, and evolocumab, but do not address Budigalimab + ABBV-382.12345
Is the drug Budigalimab a promising treatment for HIV/AIDS?
What makes the drug Budigalimab + ABBV-382 unique for treating HIV/AIDS?
Budigalimab + ABBV-382 is unique because it combines two components that may work together to enhance the immune response against HIV, potentially offering a new approach compared to traditional antiretroviral therapies. This combination could provide a novel mechanism of action by utilizing antibodies to target the virus, which might help in reducing viral load and limiting the emergence of resistant strains.678910
What data supports the idea that Budigalimab + ABBV-382 for HIV/AIDS is an effective drug?
The available research does not provide specific data on the effectiveness of Budigalimab + ABBV-382 for HIV/AIDS. The studies focus on drug resistance in HIV treatments and do not mention Budigalimab + ABBV-382. Therefore, there is no direct evidence from the provided information to support the effectiveness of this drug for HIV/AIDS.1112131415
Who Is on the Research Team?
ABBVIE INC.
Principal Investigator
AbbVie
Are You a Good Fit for This Trial?
Adults living with HIV on stable ART for at least a year, with CD4+ T cell counts >= 500 cells/μL and undetectable viral load for 6 months can join. They must be in good health as determined by medical exams. Those with significant health risks, a history of low CD4+ counts (<=200 cells/μL), or other conditions that may risk their safety or study integrity cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive 4 doses of intravenous (IV) budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo over an 8 week dosing period
Treatment Part 2
Eligible participants receive 4 doses of open-label subcutaneous (SC) Budigalimab over a 6 week dosing period
Analytical Treatment Interruption (ATI)
Participants undergo a closely monitored ART interruption for up to 112 weeks or until meeting specific criteria to restart antiretroviral medications
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-382
- Budigalimab
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois