Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026
Phase 2 Trial of Long-Acting Cabotegravir and VRC07-523LS for Viral Suppression in Adults With HIV-1: ACTG A5357.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Broadly neutralizing antibodies for HIV therapy in clinical trials: a systematic review.Infectious diseases of poverty · 2026Pooled it
- Genotypic challenges in implementing broadly neutralizing antibody-based long-acting HIV-1 therapies.Communications medicine · 2026Review
- Resistance Analysis of Low-Level Virologic Rebound During HIV-1 Treatment With Lenacapavir and Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab.The Journal of infectious diseases · 2026Article
- Distinct modes of evolution drive HIV escape from two broadly neutralizing antibodies.bioRxiv : the preprint server for biology · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors.
Funding
Abstract
backgroundLong-acting regimens are needed to expand antiretroviral therapy (ART) options for people with human immunodeficiency virus type 1 (HIV-1). Combining broadly neutralizing antibodies (bNAbs) with long-acting small-molecule antiretrovirals may offer an alternative to daily oral therapy.
methodsWe conducted a phase 2, open-label, single-arm trial at AIDS Clinical Trials Group (ACTG) sites across the United States. Eligible adults had HIV-1 virologically suppressed on ART for ≥2 years, CD4 count ≥350 cells/μL, and susceptibility to VRC07-523LS (half-maximal inhibitory concentration ≤0.25 µg/mL; inhibition >98%). Participants completed an oral cabotegravir (CAB) lead-in (Step 1), then received intravenous VRC07-523LS (40 mg/kg every 8 weeks) plus intramuscular CAB-LA (every 4 weeks) for 48 weeks (Step 2), followed by a return to standard ART (Step 3). Primary outcomes were treatment-related grade ≥3 adverse events (AEs), treatment discontinuation, and confirmed HIV-1 RNA ≥200 copies/mL by week 44. Virologic efficacy was assessed using Kaplan-Meier estimates.
resultsSeventy-four participants were enrolled (median age, 54 years; 26% female; 51% non-Hispanic White). Twelve (17%) experienced a primary safety event: 11 (15%) had grade ≥3 AEs, primarily transient infusion reactions, and 1 discontinued due to a grade 1 infusion event. The cumulative probability of virologic failure by week 44 was 7% (95% confidence interval, 3%-16%). One participant developed the R263K integrase resistance mutation.
conclusionsThe VRC07-523LS plus CAB-LA regimen maintained viral suppression in 93% of participants, with only transient infusion reactions observed; however, instances of virologic breakthrough suggest that future studies should focus on optimizing efficacy outcomes. These results support continued investigation of bNAb-based long-acting ART combinations.
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