Trial reportJournal of acquired immune deficiency syndromes (1999)2016
Dendritic Cell Immunotherapy for HIV-1 Infection Using Autologous HIV-1 RNA: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
Trial report in Journal of acquired immune deficiency syndromes (1999), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 51 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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
51 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Time to HIV viral rebound and frequency of post-treatment control after analytical interruption of antiretroviral therapy: an individual data-based meta-analysis of 24 prospective studies.Nature communications · 2025Pooled it
- Dendritic Cell-Based Immunotherapies to Fight HIV: How Far from a Success Story? A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2016Pooled it
- Virological and Immunological Outcomes of Combined Therapeutic Interventions and Dendritic Cell Therapy in People With HIV.The Journal of infectious diseases · 2025Trial
- Immunogenicity of personalized dendritic-cell therapy in HIV-1 infected individuals under suppressive antiretroviral treatment: interim analysis from a phase II clinical trial.AIDS research and therapy · 2022Trial
- Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection.AIDS research and human retroviruses · 2018Trial
- A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection.Science translational medicine · 2017Trial
- Cell-Mediated Immune Predictors of Vaccine Effect on Viral Load and CD4 Count in a Phase 2 Therapeutic HIV-1 Vaccine Clinical Trial.EBioMedicine · 2017Trial
- Enhancing mRNA stability and translational potential through tailored modifications at the 3' end.RSC chemical biology · 2026Article
- Induction of HIV-Specific T Cell Responses Using αDC1 Pulsed With Conserved HIV-1 Peptides.Journal of immunology research · 2026Article
- mRNA vaccines against viral pathogens: molecular design, delivery systems, and clinical applications.Frontiers in microbiology · 2026Review
- A review of vaccinology andHuman vaccines & immunotherapeutics · 2025Review
- Review
- mRNA-based HIV-1 vaccines.Clinical microbiology reviews · 2024Review
- Revolutionizing viral disease vaccination: the promising clinical advancements of non-replicating mRNA vaccines.Virology journal · 2023Review
- HIV Reservoir: How to Measure It?Current HIV/AIDS reports · 2023Review
- Development of therapeutic vaccines for the treatment of diseases.Molecular biomedicine · 2022Review
- Engaging innate immunity in HIV-1 cure strategies.Nature reviews. Immunology · 2022Review
- Delivery of mRNA for regulating functions of immune cells.Journal of controlled release : official journal of the Controlled Release Society · 2022Review
- Nanotechnologies in Delivery of DNA and mRNA Vaccines to the Nasal and Pulmonary Mucosa.Nanomaterials (Basel, Switzerland) · 2022Review
- A Tale of Three Recent Pandemics: Influenza, HIV and SARS-CoV-2.Frontiers in microbiology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundThe genomic heterogeneity of HIV-1 impedes the ability of consensus sequences in vaccines to elicit effective antiviral immune responses. AGS-004 amplifies translation-competent RNA molecules encoding for Gag, Rev, Vpr, and Nef from the patient's autologous virus and loads them into dendritic cells.
methodsThis phase IIB, multicenter, 2:1 randomized, double-blind, placebo-controlled study enrolled 54 HIV-1-infected patients on antiretroviral therapy with viral loads (VLs) <50 copies per milliliter, current CD4 T-cell counts >450 cells per cubic millimeter, and nadir counts >200 cells per cubic millimeter, to receive intradermal injections of study product into the axillary lymph node region every 4 weeks. At week 16, a 12-week analytical treatment interruption (ATI) was undertaken.
resultsThere was no difference in the end-of-ATI VL (average of values from weeks 11 and 12) between the 2 arms of the study [4.39 (4.17, 4.69) vs. 4.47 (3.76, 4.64) log10 HIV-1 RNA; P = 0.73]. Between arms, no change between pre-antiretroviral therapy VL and the end-of-ATI VL [-0.06 (0.24, -0.32) vs. -0.17 (0.17, -0.32) log10 HIV-1 RNA; P = 0.43] was observed. When interferon-γ, interleukin-2, tumor necrosis factor α, CD107a, and granzyme b expressions were measured by multicolor flow cytometry, a greater percentage of AGS-004 than of placebo recipients had multifunctional cytotoxic T-lymphocyte responses induced in the CD28+/CD45RA-CD8 effector/memory T-cell population to dendritic cells electroporated with autologous antigens. Adverse events consisted of transient, mild (grade 1) local injection site reactions.
conclusionsDespite the induction of HIV-specific effector/memory CD8 T-cell responses, no antiviral effect was seen after the administration of AGS-004 when compared with placebo.
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Identifiers
What OpenQuestion holds
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.