Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2021
Clinical and Immunologic Outcomes After Immediate or Deferred Antiretroviral Therapy Initiation During Primary Human Immunodeficiency Virus Infection: The Sabes Randomized Clinical Study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01815580 (HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru), which is not on this map. Cited by 16 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.
HIV Testing and Treatment to Prevent Onward HIV Transmission Among MSM and Transgender Women in Lima, Peru
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Effect of same-day HIV treatment initiation (SDI) on 1-year outcomes in low- and middle-income countries: systematic review and meta-analysis of randomised trials.BMJ global health · 2025Pooled it
- Initiation of Antiretroviral Therapy during Primary HIV Infection: Effects on the Latent HIV Reservoir, Including on Analytic Treatment Interruptions.AIDS reviews · 2020Pooled it
- Implementation of REDCap mobile app in an oral HIV clinical study.BMC public health · 2024Trial
- Central Nervous System HIV Persistence and Clinical Consequences During Suppressive ART.Current HIV/AIDS reports · 2026Review
- CD4-mimetics sensitize HIV-infected cells to ADCC mediated by plasma from persons with early-stage HIV-1 infection.Journal of virology · 2025Article
- Staging of immuno-virological dynamics during acute HIV infection in a Belgian prospective cohort study.Journal of virus eradication · 2024Article
- Incidence of low-level viremia and its impact on virologic failure among people living with HIV who started an integrase strand transfer inhibitors: a longitudinal cohort study.BMC infectious diseases · 2024Article
- Observational study of effects of HIV acquisition and antiretroviral treatment on biomarkers of systemic immune activation.PloS one · 2024Observational
- Article
- Dynamic immune markers predict HIV acquisition and augment associations with sociobehavioral factors for HIV exposure.iScience · 2022Article
- Single-cell multiomics reveals persistence of HIV-1 in expanded cytotoxic T cell clones.Immunity · 2022Article
- An Ethical Imperative to Ensure Uninterrupted HIV Care Following Therapeutic Trials: One Experience in Peru.AIDS patient care and STDs · 2022Article
- Immune Activation in Primary Human Immunodeficiency Virus: Influence of Duration of Infection, Treatment, and Substance Use.Open forum infectious diseases · 2022Article
- Virological and Immunological Outcomes of an Intensified Four-Drug versus a Standard Three-Drug Antiretroviral Regimen, Both Integrase Strand Transfer Inhibitor-Based, in Primary HIV Infection.Pharmaceuticals (Basel, Switzerland) · 2022Article
- Long-term effects of early antiretroviral initiation on HIV reservoir markers: a longitudinal analysis of the MERLIN clinical study.The Lancet. Microbe · 2021Article
- The single-cell landscape of immunological responses of CD4+ T cells in HIV versus severe acute respiratory syndrome coronavirus 2.Current opinion in HIV and AIDS · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundIn addition to demonstrated public health benefits on reducing transmission, it remains unclear how early antiretroviral therapy (ART) must be started after acquisition of human immunodeficiency virus (HIV) to maximize individual benefits.
methodsWe conducted an open-label randomized clinical study in Lima, Peru among adult men who have sex with men and transgender women with acute (HIV-antibody negative/HIV-1 RNA positive) or recent (confirmed negative HIV-antibody or RNA test within 3 months) HIV infection, who were randomized to start ART immediately versus defer by 24 weeks. We evaluated outcomes by treatment arm and immunologic markers by days since estimated date of detectible infection (EDDI).
resultsOf 216 participants, 105 were assigned to immediate arm and 111 to deferred arm (median age 26.8 years, 37% with acute HIV). The incidence of non-ART-related adverse events was lower in immediate versus deferred arm (83 vs 123/100 person-years, IRR 0.67 (95% confidence interval [CI] .47, .95; P = .02), the difference dominated by fewer infections in those treated immediately. After 24 weeks of ART, between-group differences in CD4/CD8 cell ratio lessened (P = .09 overall), but differences between those initiating ART ≤ 30 days from EDDI (median 1.03, interquartile range [IQR] 0.84, 1.37), and those initiating > 90 days (0.88, IQR 0.61, 1.11) remained, P = .02. Principal components analysis of 20 immune biomarkers demonstrated distinct patterns between those starting ART > 90 days from EDDI versus those starting within 30 or 90 days (both P < .001).
conclusionsTo our knowledge, this is the only evaluation of randomized ART initiation during primary HIV and provides evidence to explicitly consider acute HIV in World Health Organization recommendations for universal ART. CLINICAL TRIALS REGISTRATION: NCT01815580.
Indexed as
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.