NCT06031272

Pausing Antiretroviral Treatment Under Structured Evaluation

A Phase I, Randomized, Placebo-Controlled Study of the Safety, Antiviral & Immunomodulatory Activity of Broadly Neutralizing Antibodies 3BNC117-LS-J and 10-1074-LS-J in Combination in ART-treated Adults in Sub-Saharan Africa Living With HIV During a Monitored Analytical Treatment Interruption

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Network
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to see if it is safe to give the study antibodies (3BNC117-LS-J and 10-1074-LS-J) by intravenous infusion to people with HIV (PWH), and to see if they cause any side effects. In addition, to see how the study antibodies affect the level of HIV in the blood when participants are not taking regular HIV treatment for an extended period. This extended period of not taking regular HIV treatment is called an analytical treatment interruption (ATI).

Conditions

• HIV-1-infection

Interventions

Type	Name	Description
DRUG	3BNC117-LS-J	Administered by intravenous (IV) infusion
DRUG	10-1074-LS-J	Administered by intravenous (IV) infusion
DRUG	Placebo for 3BNC117-LS-J	Administered by intravenous (IV) infusion
DRUG	Placebo for 10-1074-LS-J	Administered by intravenous (IV) infusion

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-10-14
• Completion: 2026-06-30
• First posted: 2023-09-11
• Last updated: 2026-04-07

Locations

9 sites across 3 countries: Botswana, Malawi, South Africa

Regulatory

• FDA-regulated drug study