← Back to Search

Janus Kinase (JAK) Inhibitor

Baricitinib 2 MG Oral Tablet for HIV/AIDS

Phase 2

Recruiting

Led By William Tyor, MD

Research Sponsored by William Tyor

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and study week 10

Awards & highlights

Study Summary

This trial will study whether the drug baricitinib, which is already FDA-approved for treating rheumatoid arthritis, can help to decrease HIV in the central nervous system.

Who is the study for?

This trial is for adults with HIV/AIDS who have been on antiretroviral therapy (ART) with undetectable viral loads for at least a year and have CD4+ counts over 350. Women must use contraception or be postmenopausal. Exclusions include those under 18 or over 65, history of blood clots, stroke, heart failure, liver cirrhosis, recent serious infections including COVID-19, certain cancers, major surgery within the last two months or planned during the study.Check my eligibility

What is being tested?

The trial tests Baricitinib's ability to reduce HIV in the central nervous system compared to a placebo. Participants will undergo bloodwork, neurocognitive testing, MRIs and lumbar punctures to assess changes in CNS HIV levels and any improvements in brain function and inflammation markers.See study design

What are the potential side effects?

Potential side effects of Baricitinib may include infection risk due to immune suppression; possible impact on liver enzymes; blood disorders like low hemoglobin or platelets; increased cholesterol levels; nausea; headaches; allergic reactions including rash.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and study week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and study week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and study week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in CSF HIV RNA by single copy assay

Changes in CSF HIV cell associated CSF HIV DNA by Double-R assay

Biological Assay

+3 more

Secondary outcome measures

Change in HIV DNA levels by Integrated proviral DNA assay

Mental Depression

Changes in Blood CXCL10

+20 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BaricitinibExperimental Treatment1 Intervention

Potential participants will be pre-screened through review of the electronic medical record from Emory or Grady. Or if a potential participant receives care elsewhere, a release of medical information form will be signed and sent to the medical center that the individual goes to. The study team will enroll individuals who have well controlled HIV. Participants will then be randomized to either baricitinib or placebo. Patients randomized to Baricitinib group will receive Baricitinib at dose of 2 mg oral for ten weeks. Follow up visits will happen for both groups at weeks 1, 2, 4 and 10.

Group II: PlaceboPlacebo Group1 Intervention

Potential participants will be pre-screened through review of the electronic medical record from Emory or Grady. Or if a potential participant receives care elsewhere, a release of medical information form will be signed and sent to the medical center that the individual goes to. The study team will enroll individuals who have well controlled HIV. Participants will then be randomized to either baricitinib or placebo. Patients randomized to the placebo group will receive 2 mg oral daily placebo for ten weeks. Follow up visits will happen for both groups at weeks 1, 2, 4 and 10.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

William TyorLead Sponsor

Emory UniversityLead Sponsor

1,639 Previous Clinical Trials

2,560,551 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,661 Total Patients Enrolled

Media Library

Baricitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05452564 — Phase 2

HIV/AIDS Research Study Groups: Baricitinib, Placebo

HIV/AIDS Clinical Trial 2023: Baricitinib Highlights & Side Effects. Trial Name: NCT05452564 — Phase 2

Baricitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05452564 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Baricitinib 2 MG Oral Tablet been given a nod of approval by the FDA?

"Baricitinib 2 MG Oral Tablet was assigned a rating of 2 due to the limited evidence regarding its efficacy, with prior data only confirming its safety."

Answered by AI

What is the primary goal of this medical experiment?

"This clinical trial's primary objective will be assessed over Baseline and study week 10, examining changes in Cerebral-Spinal Fluid (CSF) HIV cell associated DNA levels via the Double-R Assay. Secondary objectives include Stroop Test (Color Naming & Color Word), Hopkins Verbal Learning Test II (Learning & Recall), and Grooved Pegboard Test measurements - all of which serve to evaluate motor functioning, attention, executive functioning, visual coordination and fine motor skills with snacks provided between assessments for participants taking breaks as needed."

Answered by AI

Who meets the criteria to enroll in this experiment?

"This clinical trial is searching for 95 adults, aged 18-65, who have been diagnosed with AIDS. Furthermore, applicants must also meet other requirements such as maintaining a plasma HIV RNA <200 copies/ml and CD4+ >350 cells/microliter for at least 12 months (on two preceding clinic visits). Additionally, women of childbearing age will need to pass the pregnancy test before entry and agree to contraception while on medication. Women over 50 years old and amenorrheic for more than one year are not bound by this provision."

Answered by AI

Is there an age-threshold for enrolment in this medical investigation?

"This medical trial is accepting individuals aged 18 and above, but below 65 years old."

Answered by AI

Is enrollment for this trial still available?

"As per the information hosted on clinicaltrials.gov, this medical study is not presently accepting patients. This trial was posted of 10th October 2022 and its details were last updated a few days ago at 9th September 2022. Despite that, there are still 636 other studies open for recruitment right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Baricitinib for Reduction of HIV - CNS

William Tyor 2023. "Baricitinib for Reduction of HIV - CNS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05452564.