Evaluation of the Impact of a Broadly Neutralizing Antibody and Attachment Inhibitor on Viral Reservoirs in HIV Patients on Integrase Inhibitor-Based Antiretroviral Therapy

The primary objective of this exploratory study is to evaluate the impact of incorporating a broadly neutralizing antibody, either alone or in combination with an attachment inhibitor, into an integrase inhibitor-based antiretroviral therapy regimen on the viral reservoir in adults living with HIV infection. Assessing these components is clinically significant for understanding potential strategies to reduce the persistence of latent virus. The study scope includes efficacy (5) and pharmacodynamics (7).

This clinical trial involves a total of 28 patients. The study population includes both males and females within the age ranges corresponding to codes 3 and 4. All participants are diagnosed with HIV infection. The sponsor did not provide information regarding the selection process, general health status, or lifestyle considerations.

This Phase 3, exploratory study is designed to investigate the impact on the viral reservoir of adding a broadly neutralizing antibody with or without an attachment inhibitor to an integrase inhibitor-based antiretroviral therapy regimen in adults living with HIV infection. The clinical trial methodology utilizes a randomized and controlled approach. The study sequence begins with a screening visit to determine eligibility, followed by scheduled follow-up visits to monitor clinical outcomes and therapeutic impact. The protocol concludes with an end-of-study visit. The estimated duration of participant involvement and overall study activities extends from August 2025 to March 2028. Early termination from the study may occur based on predefined clinical conditions or safety protocols.

The assessment of efficacy in this study involving patients with HIV infection is not specified.