Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in AIDS Patients
Study Details
Study Description
Brief Summary
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To evaluate the efficacy and safety of taking T8 once daily on treating chronic abnormal immune activation in AIDS patients.
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To explore dose-effect relationships of taking T8 once dailyon treating chronic abnormal immune activation in AIDS patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: T8 tablet 0.5mg Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week |
Drug: T8 tablet 0.5mg
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
Other Names:
|
| Experimental: T8 tablet 1mg Oral T8 tablet with HARRT, 1mg, once daily for 48 week |
Drug: T8 tablet 1mg
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
Other Names:
|
| Placebo Comparator: Placebo Oral Placebo with HARRT, once daily for 48 week |
Drug: Placebo
Blank control.
|
Outcome Measures
Primary Outcome Measures
- CD4+ T lymphocyte count [48 week]
The changes of CD4+ T lymphocyte count before treatment
- The percentage of subjects whose CD4+ T lymphocyte count increased ≥50 /μL [48 week]
The percentage of subjects whose CD4+ T lymphocyte count increased ≥50 /μL before treatment
- The changes of inflammatory cytokines [48 week]
The quantitative changes of inflammatory cytokines（IP-10、hsCRP、IL-6）from baseline
Secondary Outcome Measures
- CD4+/CD8+T lymphocyte ratio [24 week and 48 week]
The changes of CD4+/CD8+T lymphocyte ratio before treatment
- CD4+ T lymphocyte count increased by ≥20% [24 week and 48 week]
CD4+ T lymphocyte count increased by ≥20% compared with that before treatment
- CD4+ T lymphocyte count ≥ 200 /μL [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 [24 week and 48 week]
The incidence of AE and SAE
Other Outcome Measures
- CD8+ T lymphocyte activation [24 week and 48 week]
The changes of CD8+ T lymphocyte activation (CD8+CD38+%，CD8+HLA-DR+%) compared with that before treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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1.Male or female whose age is 18-65.
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2.Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg.
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3.Chronic HIV infections with treated by HAART over 4 years.
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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.
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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.
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7.Understand and sign informed consent voluntarily.
Exclusion Criteria:
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1.Have a history of allergic to tripterygium wilfordii drugs; be allergic constitution.
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2.Pregnant or lactating women.
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3.Those who had received immunosuppressant or other immunomodulator (e.g., thymosin) or systemic cytotoxic drug therapy within 6 months befor screening.
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4.Diagnosed with other types of immunodeficiency.
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5.Active opportunistic infection.
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6.The titers of antinuclear antibody is higher than 1:160.
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7.HBsAg was (+), and/or anti-HCV and HCV-RNA were (+)
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8.Who have a history of vaccination within 6 weeks or plan to be vaccinated in the next year.
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9.Diagnosed with malignant tumors.
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10.the laboratory test meets any of the following conditions:
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hemoglobin (HGB) < 100g/L;
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white blood cell (WBC) count < 3.5×109/L or neutrophil count (NEUT) < 1.5×109/L;
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platelet count (PLT) < 80×10^9/ L;
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blood creatinine (Cr)>1.5 times normal upper limit (ULN);
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alanine aminotransferase (ALT) > double normal upper limit (ULN);
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aspartate transaminase (AST) > double normal upper limit (ULN);
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alkaline phosphatase (ALP) > double normal upper limit (ULN);
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total bilirubin (TBIL) > 1.5 times normal upper limit (ULN).
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11.Diagnosed with Severe gastrointestinal disease.
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12.Diagnosed with severe cardiovascular disease (including unstable angina pectoris, severe arrhythmia)
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13.Diagnosed with Severe cerebrovascular disease
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14.Having a history of alcohol and drug abuse.
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15.Participate in other clinical trials within 3 months before screening.
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16.Any other conditions that the researcher considers not to be able to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100032 |
| 2 | Beijing Dita Hospital, Capital Medical University | Beijing | Beijing | China | |
| 3 | Beijing You An Hospital, Capital Medical University | Beijing | Beijing | China | |
| 4 | The First Hospital of Changsha | Changsha | Hunan | China | |
| 5 | The Second Hospital of Nanjing | Nanjing | Jiangsu | China | |
| 6 | The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Shanghai Pharmaceuticals Holding Co., Ltd
Investigators
- Principal Investigator: Taisheng Li, PhD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- T8-201