Status:
COMPLETED
Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
Lead Sponsor:
Shanghai Pharmaceuticals Holding Co., Ltd
Conditions:
Chronic Abnormal Immune Activation in HIV/AIDS
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT04084444
Start Date
December 25 2019
End Date
July 5 2022
Last Update
March 31 2023
Active Locations (9)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
2
Beijing Dita Hospital, Capital Medical University
Beijing, Beijing Municipality, China
3
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality, China
4
The First Hospital of Changsha
Changsha, Hunan, China