Chronic Abnormal Immune Activation in HIV/AIDS
Conditions
Keywords
Chronic abnormal immune activation, AIDS, T8, Efficacy, Safety
Brief summary
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.
Interventions
DRUGT8 tablet 0.5mg
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
DRUGT8 tablet 1mg
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
DRUGPlacebo
Blank control.
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chinese subjects aged 18-65, male or female； 2. Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg； 3. Subjects must meet the criteria; 4. No birth planning； 5. Understand and sign informed consent form voluntarily.
Exclusion criteria
1. allergic constitution； 2. Pregnant or lactating women； 3. Subjects who have been diagnosed with malignant tumors； 4. Subjects whose laboratory tests meet the conditions； 5. Subjects who have been diagnosed with severe gastrointestinal diseases； 6. Subjects who have been diagnosed with severe cardiovascular disease； 7. Subjects who have been diagnosed with severe cerebrovascular disease； 8. Subjects with history of alcohol and drug abuse； 9. Subjects who have participated in any other clinical trial； 10. Subjects who have any conditions that the investigator considers not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The changes of inflammatory factors | 48 week | The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline |
| CD4+ T lymphocyte count | 48 week | The changes of CD4+ T lymphocyte count from baseline |
| The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline | 48 week | The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects whose CD4+ T lymphocyte count ≥ 200 /μL | 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. |
| Incidence of AE and SAE | 24 week and 48 week | The incidence of AE and SAE |
| CD4+/CD8+T lymphocyte ratio | 24 week and 48 week | The changes of CD4+/CD8+T lymphocytes from baseline |
| The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline | 24 week and 48 week | The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| The changes of the proportion of CD8+ T lymphocyte activation | 24 week and 48 week | The changes of the proportion of CD8+ T lymphocyte activation (CD8+CD38+%，CD8+HLA-DR+%) from baseline |
Countries
China
Outcome results
None listed