Human Immunodeficiency Virus study: Baricitinib
Official title Baricitinib for Reduction of HIV - CNS
ClinicalTrials.gov ID: NCT05452564
What this study is testing
What is Baricitinib 2 MG Oral Tablet?
Baricitinib 2 MG Oral Tablet is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for human immunodeficiency virus.
Also referred to as Baricitinib.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- There is still no cure for the human immunodeficiency virus (HIV). While combination antiretroviral therapy (cART) is effective in decreasing deaths from HIV, infected individuals face a lifetime of treatment and many potential complications including end organ diseases such as HIV-associated neurocognitive disorders.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- HIV infected on continuous ART with plasma HIV RNA \<200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at...
- Current CD4+ \> 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening).
- Women of reproductive age will have a negative pregnancy test at study entry and agree to contraception while on the study drug.
You likely can't join if
- \ 65 years of age
- Pregnancy or breastfeeding
- Significant hematological abnormalities at screening (ANC \< 1000, Hgb\<10, platelet\< 100,000)
- History of progressive multifocal leukoencephalopathy
- Untreated latent tuberculosis infection (which will be screened for before entry).
- Immunosuppressive medications (including corticosteroids) and anticoagulants (aspirin acceptable) within 1 month.
See the full eligibility criteria
- HIV infected on continuous ART with plasma HIV RNA \<200 copies/ml for at least 12 months (on at least two previous clinic visits and confirmed at screening).
- Current CD4+ \> 350 cells/microliter for at least twelve months (on at least two previous clinic visits and confirmed at screening).
- Women of reproductive age will have a negative pregnancy test at study entry and agree to contraception while on the study drug.
- \ 65 years of age
- Pregnancy or breastfeeding
- Significant hematological abnormalities at screening (ANC \< 1000, Hgb\<10, platelet\< 100,000)
- History of progressive multifocal leukoencephalopathy
- Untreated latent tuberculosis infection (which will be screened for before entry). If there is a prior positive test, the test does not need to be repeated at screening.
- Immunosuppressive medications (including corticosteroids) and anticoagulants (aspirin acceptable) within 1 month.
- History of deep venous thrombosis
- Coronary artery disease or history of myocardial infarction, no exclusion if greater than 3 months
- Congestive heart failure with left ventricular ejection fraction ≤40% per American Heart Association guidelines-- no exclusion if greater than 3 months
- Ever a history of stroke
- Hematologic malignancies including lymphoma and leukemia which have no evidence of cure or are at least in remission for \> 5 years
- Major surgery within 8 weeks before screening or will require major surgery during the study
- Current or recent (\<4 weeks before randomization) clinically serious viral (including COVID-19), a bacterial, fungal, or parasitic infection or any other active or recent infection.
- Symptomatic herpes simplex at the time of randomization
- Symptomatic herpes zoster infection within 12 weeks before randomization.
- History of disseminated/complicated herpes zoster (for example, ophthalmic zoster or CNS involvement).
- positive for hepatitis B surface antigen (HBsAg), or
- positive for hepatitis B core antibody (HBcAb) and positive for hepatitis B virus deoxyribonucleic acid (HBV DNA)
- Hepatitis C virus (HCV) chronic infection (hepatitis C antibody-positive and HCV ribonucleic acid [RNA]-positive), ever.
- Cirrhosis of the liver from any cause
- ALT or AST \>2 x upper limits of normal (ULN)
- alkaline phosphatase (ALP) ≥2 x ULN
- total bilirubin ≥1.5 x ULN (except patients on atazanavir, who must have total bilirubin \<2 x ULN)
- International Normalized Ratio (INR) \> 1.5
- Absolute Neutrophil Count (ANC) \<1000 cells/mm3, confirmed on repeat testing.
- Chronic kidney disease with eGFR \<40 mL/min/1.73 m2 (note that the dose of baricitinib will be reduced to 1 mg daily in participants with GFR between 40 and 60).
- Current dependence on illicit drugs except for marijuana
- Bleeding disorders such as Von Willebrand's Disease, hemophilia, or other coagulopathies as determined by history.
- Any evidence of a mass lesion by history that could lead to increased intracranial pressure and evidence of trauma to the lumbar vertebra (see LP exclusion criteria above) by history.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Cognitively impaired or Individuals with Impaired Decision-Making Capacity
- Individuals who are not able to clearly understand English
- Community Participation (if applicable)
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
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, but 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, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.