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Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients | Clinical Trials | Clareo Health

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

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

NCT04084444•Shanghai Pharmaceuticals Holding Co., Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (9)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Beijing Dita Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Beijing You An Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Hospital of Changsha

Changsha, Hunan, China

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Yun Provincial Infectious Disease Hospital

Kunming, Yunnan, China

Xixi Hospital of Hangzhou

Hangzhou, Zhejiang, China

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Tianjin Second People's Hospital

Tianjin, China

Key Dates

Start Date

December 25, 2019

Primary Completion Date

July 5, 2022

Completion Date

July 5, 2022

Last Updated

March 31, 2023

Enrollment

151

ACTUAL participants

Conditions

Chronic Abnormal Immune Activation in HIV/AIDS

Interventions

T8 tablet 0.5mg

DRUG

T8 tablet 1mg

DRUG

Placebo

DRUG