10E8.4/iMab Bispecific Antibody and VRC07-523LS Monoclonal Antibody in HIV-infected Adults

HIV-1-infection Clinical Trial

Official title: Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis

Status Recruiting

Clinical Trial Summary

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.

20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:

• Arm 1 will receive standard daily oral ART.

• Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).

• Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).

• Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.

• Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.

Clinical Trial Description

Although global initiatives have made great strides in controlling the human immunodeficiency virus (HIV) pandemic, HIV and acquired immune deficiency syndrome (AIDS) continue to impact the lives and livelihoods of a significant portion of the population. In 2019, 38 million individuals were living with HIV and 690,000 died of AIDS-related causes. Despite extensive global efforts for disease control over the last 20 years, 1.7 million individuals contract HIV annually. Antiretroviral therapy (ART) reduces morbidity and mortality associated with HIV by suppressing viral replication but does not eradicate infection. There are barriers to universal ART use that include toxicities, costs, drug resistance, and the need for lifelong adherence. To overcome these barriers, HIV broadly neutralizing antibodies (bNAbs) represent a novel approach to HIV prevention and treatment.

The primary endpoint of change in viral load will be assessed at day 14. Participants will then transition to Step 2, during which all participants will take standard daily oral ART and have viral load monitored through Step 2 week 48. ;

Related Conditions & MeSH terms

• HIV-1-infection

• NCT number: NCT05890963
• Study type: Interventional
• Source: Columbia University
• Contact: David D. Ho, MD
• Phone: 212-304-6102
• Email: dh2994@cumc.columbia.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: November 28, 2023
• Completion date: February 2025