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NCT06987318
A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection
Phase 1 trial testing VRC07-523LS in HIV-1-infection in 40 participants. Not yet recruiting.
29 August 2027
Quick facts
| Lead sponsor | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Phase | Phase 1 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 12 June 2026 |
| Primary completion | 29 August 2027 |
| Estimated completion | 7 May 2028 |
| Sites | 13 locations across United States, Brazil, Peru |
Drugs / interventions tested
- VRC07-523LS — full drug profile →
- PGT121.414.LS — full drug profile →
Conditions studied
- HIV-1-infection — all drugs for HIV-1-infection →
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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 purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT06987318
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of VRC07-523LS
Trials testing the same drug.
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- NCT06508749 — The Tatelo Plus Study · Phase 1, PHASE2 · recruiting
- NCT05719441 — A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation Dur · Phase 2 · recruiting
- NCT05769569 — Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission · Phase 1 · withdrawn
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Currently open trials in the same condition.
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Other National Institute of Allergy and Infectious Diseases (NIAID) trials
Trials by the same sponsor.
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- NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting
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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 NCT06987318 (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 National Institute of Allergy and Infectious Diseases (NIAID)
- Last refreshed: 3 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/NCT06987318.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing