Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
Effects of recombinant human interleukin 7 on T-cell recovery and thymic output in HIV-infected patients receiving antiretroviral therapy: results of a phase I/IIa randomized, placebo-controlled, multicenter study.
Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01368107 (A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients), which is not on this map. Cited by 145 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 Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients
Who cites it
145 citing papers in PubMed, 1 synthesis or guideline pooled it, 239 citations in OpenAlex.
- Adjuvant roles of interleukin-7 in enhancing T cell recovery during antiretroviral therapy for individuals with HIV: a systematic review and meta-analysis.Annals of medicine · 2025Pooled it
- A randomized, double-blind, placebo-controlled trial of IL-7 in critically ill patients with COVID-19.JCI insight · 2025Trial
- HLA-mismatched allogeneic adoptive immune therapy in patients with severely immunosuppressed AIDS: a multicenter, open-label, controlled, phase 2a study.Emerging microbes & infections · 2024Trial
- hIL-7-hyFc, A Long-Acting IL-7, Increased Absolute Lymphocyte Count in Healthy Subjects.Clinical and translational science · 2020Trial
- Interleukin-7 restores lymphocytes in septic shock: the IRIS-7 randomized clinical trial.JCI insight · 2018Trial
- Repeated Cycles of Recombinant Human Interleukin 7 in HIV-Infected Patients With Low CD4 T-Cell Reconstitution on Antiretroviral Therapy: Results of 2 Phase II Multicenter Studies.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016Trial
- Administration of interleukin-7 increases CD4 T cells in idiopathic CD4 lymphocytopenia.Blood · 2016Trial
- Effect of therapeutic intensification followed by HIV DNA prime and rAd5 boost vaccination on HIV-specific immunity and HIV reservoir (EraMune 02): a multicentre randomised clinical trial.The lancet. HIV · 2015Trial
- Decreases in colonic and systemic inflammation in chronic HIV infection after IL-7 administration.PLoS pathogens · 2014Trial
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- Clinical rationale for thymic restoration in adult immunosenescence.Immunity & ageing : I & A · 2026Review
- NT-I7, a Long-Acting Interleukin 7, Increases Lymphocyte Counts and Induces CD8+ T-cell Clonotype Expansion in Patients with Newly Diagnosed High-Grade Gliomas.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Article
- Immune non-response despite effective antiretroviral therapy in people living with HIV: A review of potential mechanisms, biomarkers and therapeutic approaches.HIV medicine · 2026Review
- Expansion and mobilization of virus-specific stem-like CD8 T cells in chronic viral infection after treatment with a long-acting IL-7, NT-I7.Cell reports · 2026Article
- Cytoskeleton proteins, the structural basis of T-lymphocyte and TEC restructure during rapid thymus regeneration.Histology and histopathology · 2025Review
- Immunosenescence: signaling pathways, diseases and therapeutic targets.Signal transduction and targeted therapy · 2025Review
- Burning Down the House: Thymic Repair and Regeneration After Acute Damage.Immunological reviews · 2025Review
- Endogenous thymic regeneration: restoring T cell production following injury.Nature reviews. Immunology · 2025Review
- Phase I study of efineptakin alfa (NT-I7) for the treatment of Kaposi sarcoma.Journal for immunotherapy of cancer · 2025Article
85 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 13 institutions in 4 countries.
Funding
Abstract
backgroundThe immune deficiency of human immunodeficiency virus (HIV) infection is not fully corrected with ARV therapy. Interleukin-7 (IL-7) can boost CD4 T-cell counts, but optimal dosing and mechanisms of cellular increases need to be defined.
methodsWe performed a randomized placebo-controlled dose escalation (10, 20 and 30 µg/kg) trial of 3 weekly doses of recombinant human IL-7 (rhIL-7) in ARV-treated HIV-infected persons with CD4 T-cell counts between 101 and 400 cells/µL and plasma HIV levels <50 copies/mL. Toxicity, activity and the impact of rhIL-7 on immune reconstitution were monitored.
resultsDoses of rhIL-7 up to 20 µg/kg were well tolerated. CD4 increases of predominantly naive and central memory T cells were brisk (averaging 323 cells/µL at 12 weeks) and durable (up to 1 year). Increased cell cycling and transient increased bcl-2 expression were noted. Expanded cells did not have the characteristics of regulatory or activated T cells. Transient low-level HIV viremia was seen in 6 of 26 treated patients; modest increases in total levels of intracellular HIV DNA were proportional to CD4 T-cell expansions. IL-7 seemed to increase thymic output and tended to improve the T-cell receptor (TCR) repertoire in persons with low TCR diversity.
conclusionsThree weekly doses of rhIL-7 at 20 µg/kg are well tolerated and lead to a dose-dependent CD4 T-cell increase and the broadening of TCR diversity in some subjects. These data suggest that this rhIL-7 dose could be advanced in future rhIL-7 clinical studies. CLINICAL TRIALS REGISTRATION: NCT0047732.
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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.