ArticleOpen forum infectious diseases2018
Randomized Clinical Trial to Assess the Impact of the Broadly Neutralizing HIV-1 Monoclonal Antibody VRC01 on HIV-1 Persistence in Individuals on Effective ART.
Article in Open forum infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02411539 (A Phase I Study to Evaluate the Safety, Tolerability, and Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB), which is not on this map. Cited by 30 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.
A Phase I Study to Evaluate the Safety, Tolerability, and Effect of a Human Monoclonal Antibody, VRC-HIVMAB060-00-AB (VRC01), on Markers of HIV Persistence in ART-treated, HIV-infected Adults
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- Broadly neutralizing antibodies for HIV therapy in clinical trials: a systematic review.Infectious diseases of poverty · 2026Pooled it
- Central Nervous System HIV Persistence and Clinical Consequences During Suppressive ART.Current HIV/AIDS reports · 2026Review
- Diverse paths to broadly neutralizing antibody escape among HIV-1 strains.Nature microbiology · 2026Article
- Genotypic challenges in implementing broadly neutralizing antibody-based long-acting HIV-1 therapies.Communications medicine · 2026Review
- Comparison of manual and automated ultrasensitive assays for residual HIV-1 in plasma from individuals on suppressive antiretroviral therapy.Journal of clinical microbiology · 2025Article
- Structural and Functional Insights into Viral and Fungal Proteins Involved in Chronic Inflammation and Their Biologic Treatments.Pharmaceutics · 2025Review
- Immune-mediated strategies to solving the HIV reservoir problem.Nature reviews. Immunology · 2025Review
- Future of bNAbs in HIV Treatment.Current HIV/AIDS reports · 2025Review
- Clinical trials of broadly neutralizing monoclonal antibodies in people living with HIV - a review.AIDS research and therapy · 2025Review
- Research on Maternal Vaccination for HIV Prevention.Clinics in perinatology · 2024Review
- HIV vaccination: Navigating the path to a transformative breakthrough-A review of current evidence.Health science reports · 2024Article
- Review
- Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisition.EBioMedicine · 2023Article
- Safety and tolerability of AAV8 delivery of a broadly neutralizing antibody in adults living with HIV: a phase 1, dose-escalation trial.Nature medicine · 2022Article
- Latency Reversal and Clearance of Persistent HIV Infection.Methods in molecular biology (Clifton, N.J.) · 2022Article
- Rectal tissue and vaginal tissue from intravenous VRC01 recipients show protection against ex vivo HIV-1 challenge.The Journal of clinical investigation · 2021Article
- Small Molecule HIV-1 Attachment Inhibitors: Discovery, Mode of Action and Structural Basis of Inhibition.Viruses · 2021Review
- Antibody-mediated depletion of viral reservoirs is limited in SIV-infected macaques treated early with antiretroviral therapy.The Journal of clinical investigation · 2021Article
- TLR-Agonist Mediated Enhancement of Antibody-Dependent Effector Functions as Strategy For an HIV-1 Cure.Frontiers in immunology · 2021Review
- Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?Frontiers in immunology · 2021Review
Corrections and comments
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Authors and funding
14 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundBroadly neutralizing monoclonal antibodies (bnMAbs) may promote clearance of HIV-1-expressing cells through antibody-dependent cell-mediated cytotoxicity. We evaluated the effect of the CD4-binding site bnMAb, VRC01, on measures of HIV-1 persistence in chronically infected individuals.
methodsA5342 was a phase 1, randomized, double-blind, placebo-controlled, parallel-arm study. Participants on effective antiretroviral therapy (ART) were randomized to receive 2 infusions of VRC01 (40 mg/kg) at entry and week 3, and 2 infusions of placebo (saline) at weeks 6 and 9; or 2 infusions of placebo at entry and week 3, and 2 infusions of VRC01 at weeks 6 and 9.
resultsInfusion of VRC01 was safe and well tolerated. The median fold-change in the cell-associated HIV-1 RNA/DNA ratio from baseline to week 6 was 1.12 and 0.83 for the VRC01 and placebo arms, respectively, with no significant difference between arms (
conclusionsIn individuals with chronic HIV-1 infection on ART, VRC01 infusions were safe and well tolerated but did not affect plasma viremia, cellular HIV-1 RNA/DNA levels, or stimulated virus production from CD4 CLINICALTRIALSGOV IDENTIFIER: NCT02411539.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.