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Study · Non-randomized trial · n = 20 · 2024

11 results

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

Chen C, Wang J, Xun J, Zhang X, Liu L, Song Z, Zhang R, Chen J, Lu H

BMC infectious diseases17 Jan 2024Cited by 10 (Europe PMC)

PMID38233816 (opens in a new tab)PMCIDPMC10792804 (opens in a new tab)DOI10.1186/s12879-024-08985-y (opens in a new tab)PepBankPUB-38233816
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Summary

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.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, CD4+ T cell count increased after thymosin alpha‑1 started, but did not differ significantly from baseline at week 24.

    In plain wordsIn people with HIV, CD4+ T cell counts rose with thymosin alpha‑1 but not significantly versus baseline at week 24.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeCD4+ T cell count at week 24
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  2. 02HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, sjTREC increased after thymosin alpha‑1 started, but did not differ significantly from baseline at week 24.

    In plain wordsIn people with HIV, a marker of new T cell output rose with thymosin alpha‑1 but not significantly versus baseline at week 24.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changesjTREC at week 24
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  3. 03HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 significantly increased the CD4+ T cell proportion.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 raised the share of CD4+ T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseCD4+ T cell proportion
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    CD4+ T cell proportion
    17.2%
    baseline
    CD4+ T cell proportion
    29.1%
    week 24

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  4. 04HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 significantly increased the proportion of naive CD4+ T cells.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 raised the share of naive CD4+ T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseNaive CD4+ T cell proportion
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Naive CD4+ T cell proportion
    17.2%
    baseline
    Naive CD4+ T cell proportion
    41.1%
    week 24

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  5. 05HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 significantly increased the proportion of naive CD8+ T cells.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 raised the share of naive CD8+ T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    IncreaseNaive CD8+ T cell proportion
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Naive CD8+ T cell proportion
    13.8%
    baseline
    Naive CD8+ T cell proportion
    26.6%
    week 24

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  6. 06HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 significantly decreased the proportion of CD4+ central memory T cells of HIV latent hosts.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 lowered the share of CD4+ central memory T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreaseCD4+ central memory T cell proportion
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    CD4+ central memory T cell proportion
    42.7%
    baseline
    CD4+ central memory T cell proportion
    10.3%
    week 24

    Source sentences

    Summary
    Meanwhile, the proportion of CD4 + central memory T cells of HIV latent hosts (42.7% vs. 10.3%, P < 0.001) significantly decreased.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  7. 07HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 decreased PD-1 expression on CD4+ T cells.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 lowered an exhaustion marker (PD-1) on CD4+ T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreasePD-1 expression on CD4+ T cells
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    PD-1 on CD4+ T cells
    14.1%
    baseline
    PD-1 on CD4+ T cells
    6.5%
    week 24

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  8. 08HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, thymosin alpha‑1 decreased PD-1 expression on CD8+ T cells.

    In plain wordsIn people with HIV and weak immune recovery, thymosin alpha‑1 lowered an exhaustion marker (PD-1) on CD8+ T cells.

    Peptide
    Thymosin alpha-1
    Outcome
    DecreasePD-1 expression on CD8+ T cells
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    PD-1 on CD8+ T cells
    8.5%
    baseline
    PD-1 on CD8+ T cells
    4.1%
    week 24

    Source sentences

    Summary
    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.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  9. 09HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, TIM-3 expression on T cells remained unaltered at week 24.

    In plain wordsIn people with HIV and weak immune recovery, the exhaustion marker TIM-3 on T cells did not change at week 24.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeTIM-3 expression on T cells
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    but the expression of TIM-3 on T cellsremained unaltered at week 24.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  10. 10HumanNon-randomized trialSafety outcome

    In immunological nonresponders living with HIV, no severe adverse events were reported during thymosin alpha‑1 treatment.

    In plain wordsIn people with HIV and weak immune recovery, no severe side effects were reported during thymosin alpha‑1 treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeSevere adverse events
    Study

    n = 20

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    No severe adverse events were reported
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.
  11. 11HumanNon-randomized trialEfficacy outcome

    In immunological nonresponders living with HIV, HIV viral loads kept stable throughout thymosin alpha‑1 treatment.

    In plain wordsIn people with HIV and weak immune recovery, the HIV viral load stayed stable during thymosin alpha‑1 treatment.

    Peptide
    Thymosin alpha-1
    Outcome
    No significant changeHIV viral load
    Study

    n = 20

    Comparator
    Baseline
    Outcome group
    Antiviral activity · Infection
    Studied dose
    1.6 mg · subcutaneous · 24 weeksAs given in this study (human).

    Source sentences

    Summary
    HIV viral loads kept stable throughout the study.
    2 context sentences
    Summary · context
    INRs 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.
    Summary · context
    Twenty three INRs were screened for eligibility, and 20 received treatment.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedEarly phase 1NCT04963712

Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder

Shanghai Public Health Clinical Centern = 201 Sept 2021 to 11 Aug 2022

HIV-1-infection

Trial pageClinicalTrials.govUpdated 18 Jul 2023

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 3Current

    10 Oct 2026, 08:19 UTC

    Study results updated

  2. Version 2

    9 Oct 2026, 03:03 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:02 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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