Last reviewed · How we verify
NCT06031272: PAUSE
Pausing Antiretroviral Treatment Under Structured Evaluation
Phase 1 trial testing 3BNC117-LS-J in HIV-1-infection in 32 participants. Participants enrolled and being followed up; not accepting new ones.
14 October 2025
Quick facts
| Lead sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
|---|---|
| Phase | Phase 1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 28 May 2024 |
| Primary completion | 14 October 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 9 locations across Botswana, Malawi, South Africa |
Drugs / interventions tested
- 3BNC117-LS-J — full drug profile →
- 10-1074-LS-J — full drug profile →
- Placebo for 3BNC117-LS-J — full drug profile →
- Placebo for 10-1074-LS-J — full drug profile →
Conditions studied
- HIV-1-infection — all drugs for HIV-1-infection →
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):
-
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 -
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:
- PubMed search for NCT06031272
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of 3BNC117-LS-J
Trials testing the same drug.
- NCT04173819 — Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Health · Phase 1, PHASE2 · completed
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Currently open trials in the same condition.
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Other Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections trials
Trials by the same sponsor.
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- NCT05985642 — Observational PIC Destination Cohort · recruiting
- NCT05156658 — Pharmacokinetic Interactions of ENG Subdermal Implants with Long-Acting Cabotegravir (CAB-LA) and LA Rilpivirine (RPV-LA · Phase 4 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06031272 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
- Last refreshed: 7 April 2026
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