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Also known as Antiretroviral Therapy (ART)
Antiretroviral Therapy · 1 trial · 2 indications
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).
Participants who permanently discontinued study drug due to treatment-related adverse events.
Number of participants experiencing treatment-emergent adverse events (TEAEs), including serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Baricitinib 2mg | EXPERIMENTAL | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 2 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant qualifies for ART restart criteria before the end of the maximum 25 weeks of Step 2, they will move to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
| Baricitinib 4mg | EXPERIMENTAL | Adults with well-controlled HIV on ART will be treated for 25 weeks with baricitinib 4 mg per day orally plus their current ART regimen (Step 1). Following 25 weeks of baricitinib plus ART, ART will be interrupted, and the participants will be treated with baricitinib alone for up to 25 weeks (Step 2). If a participant meets the ART restart criteria before the end of the maximum 25 weeks of Step 2, they will advance to Step 3 early and resume ART, while baricitinib will be discontinued for 25 weeks. Otherwise, participants will remain on baricitinib alone until the end of the 25 weeks of Step 2 and will then resume ART while baricitinib is discontinued for an additional 25 weeks of observation (Step 3). |
| Name | Type | Description |
|---|---|---|
| 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 |
Inclusion Criteria: * 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), ...
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Antiretroviral Therapy (ART) is used for the treatment of HIV Infection. It is a small molecule therapy being developed by Eli Lilly and Company. The drug is currently in Phase 2 clinical development for this indication.
Antiretroviral Therapy is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HIV Infection.
Antiretroviral Therapy is currently in Phase 2 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 2 trial is designed to assess its potential as a treatment for HIV Infection.
Antiretroviral Therapy is being studied in a Phase 2 clinical trial with the identifier NCT07209267, titled 'Baricitinib Curative Repression of HIV-1'. This trial is not yet recruiting and aims to enroll 35 participants in the United States. The study is open to adults aged 18 years and older.
Yes, Antiretroviral Therapy is also known as Antiretroviral Therapy (ART). The drug is referred to by this alternative name in clinical and research contexts. This naming helps ensure that readers searching for either term can find consistent information about the same investigational therapy.