Baricitinib Curative Repression of HIV-1

ConditionsHIV Infection HIV

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-70

SponsorEmory University

About this trial

This study is being done to test whether a drug called baricitinib, which blocks specific causes of inflammation, affects HIV-1 viral rebound and viral load levels after HIV treatment is discontinued. Researchers will test the effects of continuing baricitinib in people with HIV before and after discontinuing their antiretroviral therapy. This drug is approved by the Food and Drug Administration (FDA) for other diseases; it is not approved for the treatment of HIV-1. The study team will also investigate any side effects associated with the drug.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Documented HIV infection

On continuous ART for at least 96 weeks before enrollment, with no interruption of ART for 7 consecutive days or longer in the 48 weeks before enrollment.

Plasma HIV-1 RNA levels of <50 copies/mL for at least 96 weeks (a minimum of two measures), and <50 copies/mL for a sample obtained within 90 days before enrollment.

CD4+ T-cell count ≥500 cells/mm3 obtained within 90 days prior to enrollment

Disqualifiers

< 18 years of age or > 70 years of age

Pregnancy or breastfeeding, as determined by a blood pregnancy test

History of AIDS-defining illness, except for recurrent pneumonia.

History of progressive multifocal leukoencephalopathy or clinically significant HIV-associated neurocognitive disease.

Trial design

Design model

Parallel

Treatments tested in this trial

Antiretroviral Therapy (ART)
Drug
Antiretroviral Therapy (ART): A treatment regimen for HIV infection that uses a combination of antiretroviral drugs to suppress viral replication, reduce HIV-related morbidity, and prevent transmission. In Step 1, participants will continue their current ART regimen for 25 weeks. In Step 2, participants will interrupt ART. In Step 3, participants will restart ART early if they meet the ART restart criteria before the end of Step 2 (a 25-week maximum). Otherwise, they will resume ART at the end of Step 2.
Baricitinib (LY3009104) 2 mg
Drug
Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 2 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 2 mg orally daily for up to an additional 25 weeks
Baricitinib (LY3009104) 4 mg
Drug
Baricitinib is an orally administered, selective inhibitor of Janus kinase (JAK) 1 and 2. It reduces cytokine-mediated signaling involved in inflammation and immune activation. Baricitinib is FDA-approved for rheumatoid arthritis (RA), atopic dermatitis, and alopecia areata. It has also been authorized for the treatment of COVID-19 in hospitalized patients. During Step 1, Baricitinib will be taken at a dose of 4 mg orally daily for 25 weeks. During Step 2, Baricitinib alone will be continued at a dose of 4 mg orally daily for up to an additional 25 weeks

Treatment groups

35 Participants

are divided into 2 treatment groups

Group A: Baricitinib 2mgExperimental treatment 2 interventions

Group B: Baricitinib 4mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Time to restart ART

Time to restart ART will be defined by a plasma HIV-1 RNA viral load greater than or equal to 1000 copies/mL following withdrawal of ART during 25 weeks of baricitinib treatment alone (following 25 weeks of baricitinib plus ART).

Time frame

Up to 25 weeks after the baricitinib treatment alone was started

Number of Participants who discontinued treatment due to adverse events

Participants who permanently discontinued study drug due to treatment-related adverse events.

Time frame

Up to 25 weeks after the start of baricitinib alone was started

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.

Time frame

Up to 25 weeks after the start of baricitinib alone was started

Secondary outcomes

Time to a detectable plasma HIV-1 RNA viral load

Time to a detectable plasma HIV-1 RNA viral load (defined as greater than the lower limit of quantification) after analytic treatment Interruption (ATI).

Time frame

Up to 25 weeks after baricitinib alone was started.

Other outcomes

Latent intact HIV reservoir

Latent intact HIV reservoir as measured in peripheral blood primarily by Intact Proviral DNA Assay (IPDA), integrated HIV-1 DNA (Alu-PCR), cell-associated RNA, and proviral DNA (total HIV cell-associated DNA).

Time frame

Baseline and up to 25 weeks after baricitinib alone was started.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov

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