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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Abnormal Immune Activation in HIV/AIDS

Intervention / Treatment
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* Drug: T8 tablet 0.5mg
* Drug: T8 tablet 1mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: T8 tablet 0.5mg<br>Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week | Drug: T8 tablet 0.5mg<br>* Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.<br>* Other names: Leiteng Shu;|
| Experimental: T8 tablet 1mg<br>Oral T8 tablet with HARRT, 1mg, once daily for 48 week | Drug: T8 tablet 1mg<br>* Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.<br>* Other names: Leiteng Shu;|
| Placebo Comparator: Placebo<br>Oral Placebo with HARRT, once daily for 48 week | Drug: Placebo<br>* Blank control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ T lymphocyte count | The changes of CD4+ T lymphocyte count from baseline | 48 week | 
| The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline | The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline | 48 week | 
| The changes of inflammatory factors | The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline | 48 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+/CD8+T lymphocyte ratio | The changes of CD4+/CD8+T lymphocytes from baseline | 24 week and 48 week | 
| The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% 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 ≥ 200 /μL | 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. | 24 week and 48 week | 
| Incidence of AE and SAE | The incidence of AE and SAE | 24 week and 48 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T8, AIDS, Chronic abnormal immune activation, Efficacy, Safety