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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Abnormal Immune Activation in HIV/AIDS
• Intervention / Treatment: Drug: T8 tablet 0.5mg; Drug: T8 tablet 1mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Second People's Hospital
  • Beijing
    • Beijing, Beijing, China, 100032
      • Peking Union Medical College Hospital
    • Beijing, Beijing, China
      • Beijing Dita Hospital, Capital Medical University
    • Beijing, Beijing, China
      • Beijing You An Hospital, Capital Medical University
  • Hunan
    • Changsha, Hunan, China
      • The First Hospital of Changsha
  • Jiangsu
    • Nanjing, Jiangsu, China
      • The Second Hospital of Nanjing
  • Yunnan
    • Kunming, Yunnan, China, 650399
      • Yun Provincial Infectious Disease Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital, Zhejiang University
    • Hangzhou, Zhejiang, China, 310023
      • Xixi hospital of Hangzhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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
Incidence of AE and SAE	The incidence of AE and SAE	24 week and 48 week
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of the proportion of CD8+ T lymphocyte activation	The changes of the proportion of CD8+ T lymphocyte activation (CD8+CD38+%，CD8+HLA-DR+%) from baseline	24 week and 48 week

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
• Investigators: Principal Investigator: Taisheng Li, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2019
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): July 5, 2022

Study Registration Dates

• First Submitted: September 5, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 10, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 28, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Safety; Efficacy; AIDS; T8; Chronic abnormal immune activation
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: T8-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No