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Pausing Antiretroviral Treatment Under Structured Evaluation

NCT06031272 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-07

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

    lead NETWORK

Principal Investigators

  • Mina Hosseinipour, MD, MPH · University of North Carolina Global HIV Prevention and Treatment CTU

  • Rebone Maboa, MBChB, DOHM · The Aurum Institute Pretoria CRS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-10-14
Completion
2026-06-30
FDA Drug
Yes

Countries

  • Botswana
  • Malawi
  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06031272 on ClinicalTrials.gov