Trial reportThe Journal of infectious diseases2026
Effect of Delayed Antiretroviral Therapy Initiation on Anti-CD4 Autoantibodies in Antiretroviral Therapy-Naive People With HIV.
Trial report in The Journal of infectious diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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13 authors.
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Abstract
backgroundWe previously identified anti-CD4 autoantibodies in antiretroviral therapy (ART)-naive people with Human Immunodeficiency Virus (HIV) (PWH) with CD4 < 100 cells/µL using luciferase immunoprecipitation systems (LIPSs). The influence of ART initiation on anti-CD4 autoantibodies and their impact on CD4 recovery in PWH with higher CD4 counts are unclear.
methodsIn the Strategic Timing of Antiretroviral Treatment (START) trial, ART-naive PWH with CD4 > 500 cells/µL were randomized to start ART immediately (immediate) or delay until CD4 < 350 cells/µL or Acquired Immunodeficiency Syndrome (AIDS) (deferred). In a subset of participants, we measured anti-CD4 autoantibodies using LIPS from plasma samples collected at baseline and month 24. We used logistic regression models to evaluate associations with the presence of anti-CD4 autoantibodies and to compare month 24 anti-CD4 autoantibodies between treatment groups. In the immediate group, the mean change in CD4 counts from baseline to month 24 was compared by baseline anti-CD4 autoantibody serostatus.
resultsBaseline anti-CD4 autoantibody prevalence in 1199 participants (600 immediate, 599 deferred) was 41%; anti-CD4 autoantibodies were higher with recent HIV infection and among participants in Africa. At month 24, anti-CD4 autoantibody prevalence had decreased to 26% in the immediate and 31% in the deferred group (odds ratio [OR] = 2.04; P < .001). Participants with recent HIV infection had larger decreases in anti-CD4 autoantibodies (P < .001). There was no difference in CD4 recovery from baseline to month 24 by baseline anti-CD4 autoantibodies within the immediate group.
conclusionsAnti-CD4 autoantibodies are common in untreated PWH with high CD4 counts; however, with ART use, their prevalence decreases. Anti-CD4 autoantibodies are not associated with CD4 recovery in PWH with CD4 > 500 cells/µL initiating ART.
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