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

This is an interventional treatment trial for Chronic Abnormal Immune Activation in HIV/AIDS focused on measuring Chronic abnormal immune activation, AIDS, T8, Efficacy, Safety Read More

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 (the results of screening period will be accepted).

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.