ArticleAIDS (London, England)2026
Impact of AGT103-T cell and gene therapy on intact HIV proviral reservoirs.
Article in AIDS (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.
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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.
Phase 1 Study to Evaluate the Safety of Genetically Modified, Autologous T Cells in Participants With HIV That is Well-Controlled on Antiretroviral Therapy
An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact and Durability of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy(ART) in Participants With Human Immunodeficiency Virus(HIV) Previously Treated With AGT103-T
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4 authors.
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Abstract
objectiveTo assess the impact of AGT103-T, an autologous CD4 + T-cell and gene therapy, on HIV proviral DNA reservoir.
designIntact proviral DNA is quantified using the intact proviral DNA assay (IPDA). Here, IPDA was modified and analytically qualified for use in people with HIV (PWH) treated with lentiviral-based therapies and applied to samples from six participants who received AGT103-T.
methodsStandard IPDA targets overlap with sequences present in lentiviral vectors, including the AGT103-T therapeutic vector, preventing accurate quantification. We developed a modified IPDA that avoids vector interference while preserving detection of intact HIV proviruses by targeting HIV Gag and Nef regions. The assay was qualified for specificity, linearity, and reproducibility using plasmid standards and human DNA. Enriched CD4 + T cells from peripheral blood collected pretreatment, posttreatment, and during analytical treatment interruption in a Phase 1 trial (NCT04561258; NCT05540964) were analyzed.
resultsIntact proviral DNA declined in all six participants following AGT103-T treatment and reached below the assay's lower limit of detection by the end of follow-up. In contrast, defective proviral DNA showed variable changes without a consistent decline.
conclusionsAGT103-T treatment was associated with a reduction in intact HIV proviral DNA within circulating CD4 + T cells. These findings extend prior reports describing positive immune and virologic outcomes in AGT103-T-treated participants during analytical treatment interruption. The modified intact proviral DNA assay enables accurate measurement of the intact HIV reservoir in the context of lentiviral gene therapy and supports continued clinical evaluation of AGT103-T.
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