Evidence map›Paper›PMID 38233816›Full record

ArticleBMC infectious diseases2024

Role of thymosin α1 in restoring immune response in immunological nonresponders living with HIV.

Chaoyu Chen, Jiangrong Wang, Jingna Xun, Xinyu Zhang, Li Liu, Zichen Song, Renfang Zhang, Jun Chen, Hongzhou Lu

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04963712 (A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.8field-weighted citation impact, top 7% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04963712 early_phase1completednot on this map

A Prospective Single-arm Cohort Study Evaluating the Safety and Efficacy of Thymalfasin (Zadaxin®) in the Treatment of HIV-positive Patients With Immune Reconstitution Disorders

TypeinterventionalSponsorShanghai Public Health Clinical CenterRan2021 to 2022Enrolled20ConditionsHIV-1-infectionArmsZadaxin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 1 country.

Chaoyu ChenShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Jiangrong WangShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Jingna XunShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Xinyu ZhangShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Li LiuShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Zichen SongShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Renfang ZhangShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China.
Jun ChenShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China. qtchenjun@163.com.
Hongzhou LuShanghai Public Health Clinical Center, Fudan University, Caolang Road 2901, Jinshan, Shanghai, 201508, China. luhongzhou@fudan.edu.cn.
Shanghai Public Health Clinical Center · CNSouthern University of Science and Technology · CN

Funding

National Natural Science Foundation Project 82072281
6 · The paper itself

Abstract

backgroundImmunological nonresponders (INRs) living with HIV are at increased risk of co-infection and multiple tumors, with no effective strategy currently available to restore their T-cell immune response. This study aimed to explore the safety and efficacy of thymosin α1 in reconstituting the immune response in INRs.

methodsINRs with CD4 + T cell counts between 100 and 350 cells/μL were enrolled and received two-staged 1.6 mg thymosin α1 subcutaneous injections for 24 weeks (daily in the first 2 weeks and biweekly in the subsequent 22 weeks) while continuing antiretroviral therapy. T cell counts and subsets, the expression of PD-1 and TIM-3 on T cells, and signal joint T cell receptor excision circles (sjTREC) at week 24 were evaluated as endpoints.

resultsTwenty three INRs were screened for eligibility, and 20 received treatment. The majority were male (19/20), with a median age of 48.1 years (interquartile range: 40.5-57.0) and had received antiretroviral therapy for 5.0 (3.0, 7.3) years. Multiple comparisons indicated that CD4 + T cell count and sjTREC increased after initiation of treatment, although no significant differences were observed at week 24 compared to baseline. Greatly, levels of CD4 + T cell proportion (17.2% vs. 29.1%, P < 0.001), naïve CD4 + and CD8 + T cell proportion (17.2% vs. 41.1%, P < 0.001; 13.8% vs. 26.6%, P = 0.008) significantly increased. Meanwhile, the proportion of CD4 + central memory T cells of HIV latent hosts (42.7% vs. 10.3%, P < 0.001) significantly decreased. Moreover, the expression of PD-1 on CD4 + T cells (14.1% vs. 6.5%, P < 0.001) and CD8 + T cells (8.5% vs. 4.1%, P < 0.001) decreased, but the expression of TIM-3 on T cellsremained unaltered at week 24. No severe adverse events were reported and HIV viral loads kept stable throughout the study.

conclusionsThymosin α1 enhance CD4 + T cell count and thymic output albeit as a trend rather than an endpoint. Importantly, it improves immunosenescence and decreases immune exhaustion, warranting further investigation.

trial registrationThis single-arm prospective study was registered with ClinicalTrials.gov (NCT04963712) on July 15, 2021.

Indexed as

Hepatitis A Virus Cellular Receptor 2HIV InfectionsAdultCD4 Lymphocyte CountCD4-Positive T-LymphocytesFemaleHumansImmunityMaleMiddle AgedProgrammed Cell Death 1 ReceptorProspective StudiesThymalfasinHepatitis A Virus Cellular Receptor 2Programmed Cell Death 1 ReceptorThymalfasinHIVImmune responseImmunological nonrespondersThymic outputThymosin α1

Identifiers

PMID38233816
PMCPMC10792804
OpenAlexW4390947257

What OpenQuestion holds

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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.