What side effects are associated with this type of intervention?

Common treatments for HIV/AIDS include antiretroviral therapy (ART) which often involves a combination of drugs such as nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase strand transfer inhibitors (INSTIs). Known side effects of these treatments can include nausea, diarrhea, headache, fatigue, and more severe effects like liver toxicity, kidney problems, and bone density loss. For anti-inflammatory treatments like Baricitinib, which is being studied for its effects on inflammation in HIV patients, side effects may include increased risk of infections, blood clots, and changes in blood cell counts.

What prior FDA approvals exist?

The FDA has approved various treatments for HIV/AIDS, primarily focusing on antiretroviral therapies (ART) that target different stages of the HIV life cycle. While baricitinib, an anti-inflammatory drug, is being studied for its potential impact on depressive symptoms in HIV patients, it is not yet approved for HIV treatment. Current ART regimens include drugs like integrase inhibitors, protease inhibitors, and non-nucleoside reverse transcriptase inhibitors, which help manage the virus and improve immune function. Anti-inflammatory treatments specifically for HIV-related conditions are still under investigation.

What other types of research exist?

Tofacitinib is a promising, novel alternative to Baricitinib for HIV/AIDS patients considering treatment in 2024. It is another Janus kinase inhibitor that has shown efficacy in treating various inflammatory conditions.

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Anti-inflammatory

Baricitinib for Depression in People With HIV

Verified Trial

Phase 2

Recruiting

Led By Jennifer Felger, PhD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you currently depressed?

Have you been on stable antiretroviral therapy (ART) regimen for more than 1 year?

Must not have

Have you ever been diagnosed or treated for an autoimmune disorder or cancer (excluding skin cancer)?

Timeline

Screening 2 days

Treatment 10 weeks

Follow Up 2 weeks

Summary

This trial tests whether the anti-inflammatory drug baricitinib can help people with HIV and depression by reducing inflammation. The study focuses on patients who have high inflammation and are already on effective HIV treatment. Researchers want to see if lowering inflammation can improve brain functions related to pleasure and movement, potentially easing depressive symptoms.

Who is the study for?

This trial is for men and women with HIV who are stable on treatment, have depression with significant anhedonia (lack of pleasure including low motivation or feeling like everything is an effort), and high inflammation. They must not be pregnant or breastfeeding, should agree to use contraception, have a CD4+ count over 350, no major health issues like heart failure or untreated infections, and not be on certain medications.

What is being tested?

The study tests if the anti-inflammatory drug baricitinib affects depressive symptoms in people with HIV compared to a placebo. Participants will undergo medical assessments, neurocognitive testing, brain scans (fMRI), and optional spinal taps over approximately 3.5 months.

What are the potential side effects?

Baricitinib may cause side effects such as infection risk increase due to immune system suppression, blood clotting problems which could lead to deep vein thrombosis or stroke-like conditions, liver issues indicated by abnormal lab results, potential allergic reactions among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 2 days2 visits

Treatment ~ 10 weeks6 visits

Follow Up ~ 2 weeks1 visit

Screening ~ 2 days

Treatment ~ 10 weeks

Follow Up ~2 weeks

This trial's timeline: 2 days for screening, 10 weeks for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in corticostriatal functional connectivity (FC) in reward circuit

Secondary study objectives

Change in Effort Expenditure for Reward Task (EEfRT) Score

Change in Finger Tapping Task (FTT) Mean Number of Taps

Change in Finger Tapping Task (FTT) Total Number of Taps

+6 more

Side effects data

From 2015 Phase 3 trial • 1307 Patients • NCT01710358

Nasopharyngitis

Upper respiratory tract infection

Bronchitis

Influenza

Back pain

Urinary tract infection

Pharyngitis

100%

80%

60%

40%

20%

Study treatment Arm

BaricitinibTreatment B

Baricitinib Follow-up

Placebo Follow-up

Adalimumab Treatment B

Placebo Treatment B

Adalimumab Follow-up

Baricitinib Treatment A

Adalimumab Treatment A

Placebo Treatment A

Rescue

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BaricitinibExperimental Treatment1 Intervention

Participants will be randomized to receive 10 weeks of treatment with baricitinib.

Group II: PlaceboPlacebo Group1 Intervention

Participants will be randomized to receive 10 weeks of treatment with placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Baricitinib

2017

Completed Phase 3

~9510

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for HIV/AIDS include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase strand transfer inhibitors (InSTIs), and CCR5 antagonists. NRTIs and NNRTIs inhibit the reverse transcriptase enzyme, preventing the conversion of viral RNA into DNA. PIs inhibit the protease enzyme, which is crucial for the maturation of infectious viral particles. InSTIs block the integrase enzyme, preventing the integration of viral DNA into the host genome. CCR5 antagonists block the CCR5 co-receptor on host cells, preventing viral entry. These mechanisms are vital as they collectively reduce viral load, improve immune function, and prevent the progression to AIDS. Anti-inflammatory treatments like Baricitinib, although primarily studied for their role in reducing inflammation, may also benefit HIV/AIDS patients by addressing inflammation-related complications and improving overall quality of life.

Efavirenz-Based Regimens in Antiretroviral-Naive HIV-Infected Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Lessons learned from HIV treatment interruption: safety, correlates of immune control, and drug sparing.Optimal time for initiation of antiretroviral therapy in asymptomatic, HIV-infected, treatment-naive adults.