Clinical Validation and Usability Assessment of the statID Pro HBsAg Test for Point-of-Care

Summary: The purpose of the study is to conduct clinical evaluation and usability assessment of a point-of-care diagnostic test for hepatitis B.
Investigator: Yuka Manabe, MD
Project Period: 12/1/2025 – 11/30/2026 

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A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 Administered as a Single Ascending Dose and Multiple Ascending Doses in Participants with Chronic Hepatitis B Virus Infection

Summary: Hepatitis B is highly contagious, and many people do not know they have the infection, significantly contributing to its spread. There is currently no cure for hepatitis B (HBV) and existing treatments only marginally lower HBV protein levels. This leaves patients vulnerable to serious health issues including chronic infection, liver cancer and cirrhosis. GIGA-2339 is the first recombinant human polyclonal antibody therapy for HBV that has been proven in preclinical studies to be 2000 times more potent than currently available HBV treatments. This study aims to build on that work by testing GIGA-2339 in the clinical setting to determine if the therapy could provide a functional cure for hepatitis B.
Investigator: Mark Sulkowski, MD
Project Period: 9/1/2025 – 1/31/2028

Advancing Apoptosis-Inducing Agents as Host-Directed Therapy for TB

Summary: Host-directed therapies (HDTs) have the potential to significantly enhance current antibiotic regimens for tuberculosis (TB). Macrophages are the major host cell niche for Mycobacterium tuberculosis (Mtb) infection, and apoptosis (cell death), which is repressed by Mtb, constitutes an important innate defense mechanism against TB. The goal of this program is to identify clinically-relevant HDTs that maximize cell death in Mtb-infected macrophages, characterize their mode of action, and determine their potential to shorten the duration of curative treatment for drug-susceptible and drug-resistant TB in an animal model.
Investigator: Petros Karakousis, MD
Project Period: 9/3/2025 – 8/31/2029

HIV Reservoir Dynamics and Immune Responses Across the Female Reproductive Life Span

Summary: Efforts to find a cure for HIV have shown that people react differently to the virus and treatment, with factors like gender and age playing a role. This project aims to study how key life events, such as pregnancy, menopause, and aging, affect the HIV virus in Ugandan women. By closely examining the virus and the immune system over time, the research aims to fill important knowledge gaps, especially for improving treatment strategies for women with HIV variants other than the B subtype.
Investigator: Eileen Scully, MD, PhD
Project Period: 9/12/2025 – 8/31/2030

Hepatitis B and HIV Care Consortium

Summary: Chronic hepatitis B (CHB) affects over 300 million people worldwide and increases liver-related mortality 14- fold in the 10% of people with HIV who also have CHB (PWHHB). The goal of the synergistic Cores and Projects in the Hepatitis B HIV Cure Consortium (BICC) is to build a multinational, collaborative cohort of PWHHB to reveal mechanisms of HBV control in people receiving hepatitis B therapy. These data will be integrated into a model of hepatitis B control that will provide a roadmap to developing therapeutics for a hepatitis B functional cure.
Investigator: Chloe Thio, MD
Project Period: 9/17/2025 – 7/31/2030 

Macrophage Senescence As a Driver of a Granuloma Failure and Progression to Necrosis in TB and TB/HIV

Summary: Mycobacterium tuberculosis causes TB by causing the body's immune system to react in a way that damages lung tissue. This tissue damage allows the bacteria to spread to others through coughing. We found that the bacteria make immune cells enter a state similar to aging, where these cells can't respond properly to the infection. We plan to use advanced techniques to study this unusual aging response in immune cells and test new drugs in animal models to see if they could be effective treatments for TB.
Investigator: William Bishai, MD, PhD
Project Period: 9/19/2025 – 8/31/2029 

Omadacycline Companion Drugs that Minimize Antibiotic Resistance

Summary: The goal of this study is to evaluate the antibiotic omadacycline alone and in combination with companion drugs in time-kill assays against M. abscessus bacteria to determine if omadacycline prevents the development of resistance to the companion drug.
Investigator: Gyanu Lamichhane, PhD
Project Period: 10/1/2025 – 9/30/2026 

From Suppression to Elimination: Leveraging the CARD8 Inflammasome as a Global HIV Cure Strategy

Summary: This project focuses on a self-destruct mechanism embedded in cells infected with HIV. The cell sensor detects the protein HIV needs to mature. Once activated, this mechanism causes HIV-infected cells to undergo a form of cell death called pyroptosis. Previous research by Dr. Simonetti’s team has shown that a common HIV drug can activate this cell mechanism and reduce the size of the HIV reservoir. The team now plans to test new compounds that can amplify this activity.
Investigator: Francesco Simonetti, MBChB, PhD
Project Period: 10/1/2025 – 9/30/2027