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

Overview

1. To evaluate the efficacy and safety of taking T8 once daily on treating chronic abnormal immune activation in AIDS patients.

2. To explore dose-effect relationships of taking T8 once dailyon treating chronic abnormal immune activation in AIDS patients.

Full Title of Study: “To Evaluate the Efficacy and Safety of T8 on Treating Chronic Abnormal Immune Activation in AIDS Patients: A Multicenter, Randomized, Double-blind, Dose-exploration, Placebo-controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 30, 2021

Interventions

  • Drug: T8
    • Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Arms, Groups and Cohorts

  • Experimental: T8 tablet 0.25mg
    • Oral T8 tablet with HARRT, 0.25mg, once daily for 48 week
  • Experimental: T8 tablet 0.5mg
    • Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week
  • Experimental: T8 tablet 1mg
    • Oral T8 tablet with HARRT, 1mg, once daily for 48 week
  • Placebo Comparator: Placebo
    • Oral Placebo with HARRT, once daily for 48 week

Clinical Trial Outcome Measures

Primary Measures

  • CD4+ T lymphocyte count
    • Time Frame: 48 week
    • The changes of CD4+ T lymphocyte count before treatment
  • The percentage of subjects whose CD4+ T lymphocyte count increased ≥50 /μL
    • Time Frame: 48 week
    • The percentage of subjects whose CD4+ T lymphocyte count increased ≥50 /μL before treatment
  • The changes of inflammatory cytokines
    • Time Frame: 48 week
    • The quantitative changes of inflammatory cytokines(IP-10、hsCRP、IL-6)from baseline

Secondary Measures

  • CD4+/CD8+T lymphocyte ratio
    • Time Frame: 24 week and 48 week
    • The changes of CD4+/CD8+T lymphocyte ratio before treatment
  • CD4+ T lymphocyte count increased by ≥20%
    • Time Frame: 24 week and 48 week
    • CD4+ T lymphocyte count increased by ≥20% compared with that before treatment
  • CD4+ T lymphocyte count ≥ 200 /μL
    • Time Frame: 24 week and 48 week
    • The proportion of subjects with CD4+ T lymphocyte count < 200 /μL before treatment and ≥200 /μL after treatment
  • Incidence of AE and SAE
    • Time Frame: 24 week and 48 week
    • The incidence of AE and SAE

Participating in This Clinical Trial

Inclusion Criteria

  • 1.Male or female whose age is 18-65.
  • 2.Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg.
  • 3.Chronic HIV infections with treated by HAART over 4 years.
  • 4.Subjects must meet the criteria for sustained virology inhibition: maintain HIV-1 RNA below the lower limit of detection (50 copies /mL) over 3.5 years, except for transient venereal; Subjects should provide at least 2 test results of HIV-1 RNA lower than the lower limit of detection, and the earliest detection time is earlier than 3.5 years.

HIV-1 RNA should be less than 50 copies /mL at subject screening.

  • 5.Subjects must meet the criteria for immunoreestablishment insufficiency: CD4+ T lymphocyte count < 350 /μL in 1 year before screening; Test results of CD4+ T lymphocyte count < 350 /μL should be provided at least 2 times, and the interval between these two tests should be ≥3 months (except the results during screening period).

When subjects are screened for enrollment, CD4+ T lymphocyte count should be < 350 /μL.

  • 6.No birth planning during the trial and within 1 year after the trial; subjects must agree to use effective non-drug contraception during the trial.
  • 7.Understand and sign informed consent voluntarily.

Exclusion Criteria

  • 1.Have a history of allergic to tripterygium wilfordii drugs; be allergic constitution.
  • 2.Pregnant or lactating women.
  • 3.Those who had received immunosuppressant or other immunomodulator (e.g., thymosin) or systemic cytotoxic drug therapy within 6 months befor screening.
  • 4.Diagnosed with other types of immunodeficiency.
  • 5.Active opportunistic infection.
  • 6.The titers of antinuclear antibody is higher than 1:160.
  • 7.HBsAg was (+), and/or anti-HCV and HCV-RNA were (+)
  • 8.Who have a history of vaccination within 6 weeks or plan to be vaccinated in the next year.
  • 9.Diagnosed with malignant tumors.
  • 10.the laboratory test meets any of the following conditions:
  • hemoglobin (HGB) < 100g/L;
  • white blood cell (WBC) count < 3.5×10^9/L or neutrophil count (NEUT) < 1.5×10^9/L;
  • platelet count (PLT) < 80×10^9/ L;
  • blood creatinine (Cr)>1.5 times normal upper limit (ULN);
  • alanine aminotransferase (ALT) > double normal upper limit (ULN);
  • aspartate transaminase (AST) > double normal upper limit (ULN);
  • alkaline phosphatase (ALP) > double normal upper limit (ULN);
  • total bilirubin (TBIL) > 1.5 times normal upper limit (ULN).
  • 11.Diagnosed with Severe gastrointestinal disease.
  • 12.Diagnosed with severe cardiovascular disease (including unstable angina pectoris, severe arrhythmia)
  • 13.Diagnosed with Severe cerebrovascular disease
  • 14.Having a history of alcohol and drug abuse.
  • 15.Participate in other clinical trials within 3 months before screening.
  • 16.Any other conditions that the researcher considers not to be able to participate in this study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Pharmaceuticals Holding Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Taisheng Li, PhD, Principal Investigator, Peking Union Medical College Hospital
  • Overall Contact(s)
    • Zhen Tan, Master, +86-020-63730908, tanz@sphchina.com

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