Baricitinib for HIV Infection
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called baricitinib to determine if it can control HIV-1 when individuals stop their usual antiretroviral therapy (ART). Baricitinib, already used for other diseases, blocks inflammation. Researchers aim to discover its effects on virus levels in the body and any potential side effects. Individuals with well-controlled HIV, who have maintained consistent ART for about two years and have stable health markers, may be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I have to stop taking my current medications for the trial?
The trial requires participants to stop their antiretroviral therapy (HIV treatment) to test the effects of baricitinib. The protocol does not specify if other medications need to be stopped, but it excludes those who have used immunomodulatory medications recently.
Is there any evidence suggesting that baricitinib is likely to be safe for humans?
Research shows that baricitinib is generally safe for use. The FDA has already approved it for other conditions, indicating it has passed safety tests for those uses. Studies have found that it lacks a black-box warning, a serious safety alert from the FDA, suggesting it may have fewer harmful side effects compared to other treatments.
In past studies, baricitinib was used for extended periods without major safety issues. It has also shown potential in reducing inflammation and can cross the blood-brain barrier, a protective layer for the brain. This ability might help in treating brain issues related to HIV. While the side effects when used for HIV are not fully known yet, existing data for other uses indicate it is safe for long-term use.12345Why do researchers think this study treatment might be promising for HIV?
Baricitinib is unique because it targets the Janus kinase (JAK) pathway, which plays a role in immune regulation. Unlike the standard antiretroviral therapies (ART) for HIV that focus on directly inhibiting viral replication, baricitinib aims to modulate the immune response, possibly reducing inflammation and improving immune function. Researchers are excited about this approach because it might offer a complementary strategy to traditional ART, potentially helping to control the virus with fewer drugs and enhancing the overall treatment landscape for those living with HIV.
What evidence suggests that baricitinib might be an effective treatment for HIV?
Research has shown that baricitinib, the investigational treatment in this trial, can enter the brain and may help reduce HIV's presence there. Recent studies suggest that baricitinib can lower inflammation related to HIV and might also help reduce hidden virus levels in the body. Additionally, researchers have found that baricitinib improves behavior issues linked to HIV. Although not yet approved for treating HIV, these findings suggest it could help manage the condition.15678
Who Is on the Research Team?
Vincent Marconi, MD
Principal Investigator
Emory University
William Tyor, MD
Principal Investigator
Emory University
Christina Gavegnano, PhD
Principal Investigator
Emory University
Andrew H Miller, MD
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for individuals with HIV/AIDS who are currently on antiretroviral therapy (ART). Participants must be willing to temporarily stop their ART to test the effects of a drug called Baricitinib. The study aims to see if this drug, which reduces inflammation, can affect HIV-1 levels after stopping ART.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Step 1
Participants receive baricitinib combined with ART for 26 weeks
Treatment Step 2
Participants receive baricitinib alone after stopping ART for up to 24 weeks
Treatment Step 3
Participants resume ART while baricitinib is discontinued for 24 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Baricitinib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Emory University
Lead Sponsor
Eli Lilly and Company
Industry Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University