Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
- Conditions
- Chronic Abnormal Immune Activation in HIV/AIDS
- Interventions
- Drug: T8 tablet 0.5mgDrug: T8 tablet 1mgDrug: Placebo
- Registration Number
- NCT04084444
- Lead Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description T8 tablet 0.5mg T8 tablet 0.5mg Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week T8 tablet 1mg T8 tablet 1mg Oral T8 tablet with HARRT, 1mg, once daily for 48 week Placebo Placebo Oral Placebo with HARRT, once daily for 48 week
- Primary Outcome Measures
Name Time Method 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
The changes of inflammatory factors 48 week The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline
- Secondary Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (9)
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Beijing You An Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Yun Provincial Infectious Disease Hospital
🇨🇳Kunming, Yunnan, China
Tianjin Second People's Hospital
🇨🇳Tianjin, China
The First Hospital of Changsha
🇨🇳Changsha, Hunan, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
Xixi Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Beijing Dita Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China