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NCT06031272: PAUSE

Pausing Antiretroviral Treatment Under Structured Evaluation

Active, enrolled Phase 1 Last updated 7 April 2026
What this trial tests

Phase 1 trial testing 3BNC117-LS-J in HIV-1-infection in 32 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
28 May 2024
Primary endpoint
14 October 2025
30 June 2026

Quick facts

Lead sponsorAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
PhasePhase 1
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment32
Start date28 May 2024
Primary completion14 October 2025
Estimated completion30 June 2026
Sites9 locations across Botswana, Malawi, South Africa

Drugs / interventions tested

Conditions studied

Sponsor

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

Who can join

Adults 18 to 70, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.
    Mahomed S, Pillay K, Hassan-Moosa R, Galvão BPGV, et al · · 2025 · cited 20× · PMID 40189566 · DOI 10.1186/s12981-025-00734-8
  2. mRNA-Encoded Antibodies: An Emerging Paradigm in Antiviral Protection.
    Klotchenko S, Plotnikova M. · · 2026 · PMID 41750365 · DOI 10.3390/biom16020297

Verify or expand the search:

Other trials of 3BNC117-LS-J

Trials testing the same drug.

Other recruiting trials for HIV-1-infection

Currently open trials in the same condition.

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

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06031272.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing