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NCT Number: NCT04084444

Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients

This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.

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Key information

Conditions

Chronic Abnormal Immune Activation in HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Dita Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese subjects aged 18-65, male or female；
  • Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg；
  • Subjects must meet the criteria;
  • No birth planning；
  • Understand and sign informed consent form voluntarily.

Exclusion criteria

  • allergic constitution；
  • Pregnant or lactating women；
  • Subjects who have been diagnosed with malignant tumors；
  • Subjects whose laboratory tests meet the conditions；
  • Subjects who have been diagnosed with severe gastrointestinal diseases；
  • Subjects who have been diagnosed with severe cardiovascular disease；
  • Subjects who have been diagnosed with severe cerebrovascular disease；
  • Subjects with history of alcohol and drug abuse；
  • Subjects who have participated in any other clinical trial；
  • Subjects who have any conditions that the investigator considers not suitable for this trial.

Treatment and study plan

T8 tablet 0.5mg

Drug

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Other names: Leiteng Shu

T8 tablet 1mg

Drug

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Other names: Leiteng Shu

Placebo

Drug

Blank control.

Primary outcomes

  1. CD4+ T lymphocyte count

    Time frame: 48 week

    The changes of CD4+ T lymphocyte count from baseline

  2. The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline

    Time frame: 48 week

    The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline

  3. The changes of inflammatory factors

    Time frame: 48 week

    The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline

Secondary outcomes

  1. CD4+/CD8+T lymphocyte ratio

    Time frame: 24 week and 48 week

    The changes of CD4+/CD8+T lymphocytes from baseline

  2. The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline

    Time frame: 24 week and 48 week

    The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline

  3. The proportion of subjects whose CD4+ T lymphocyte count ≥ 200 /μL

    Time frame: 24 week and 48 week

    The proportion of subjects whose CD4+ T lymphocyte count after treatment is≥200/μL, among subjects with CD4+T lymphocyte counts < 200/μL at baseline.

  4. Incidence of AE and SAE

    Time frame: 24 week and 48 week

    The incidence of AE and SAE

Other outcomes

  1. The changes of the proportion of CD8+ T lymphocyte activation

    Time frame: 24 week and 48 week

    The changes of the proportion of CD8+ T lymphocyte activation (CD8+CD38+%，CD8+HLA-DR+%) from baseline

Sponsors and collaborators

Lead sponsor

Shanghai Pharmaceuticals Holding Co., Ltd

Industry

Registry information

Official study title

Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-finding, Placebo-controlled Study

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2019
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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