Clinical trial NCT04084444: Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Abnormal Immune Activation in HIV/AIDS
Keywords: Chronic abnormal immune activation
AIDS
T8
Efficacy
Safety
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: CD4+ T lymphocyte count
timeFrame: 48 week
measure: The proportion of subjects whose CD4+ T lymphocyte count increased by≥50 /μL from baseline
timeFrame: 48 week
measure: The changes of inflammatory factors
timeFrame: 48 week
Secondary outcomes:
measure: CD4+/CD8+T lymphocyte ratio
timeFrame: 24 week and 48 week
measure: The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline
timeFrame: 24 week and 48 week
measure: The proportion of subjects whose CD4+ T lymphocyte count ≥ 200 /μL
timeFrame: 24 week and 48 week
measure: Incidence of AE and SAE
timeFrame: 24 week and 48 week
Other outcomes:
measure: The changes of the proportion of CD8+ T lymphocyte activation
timeFrame: 24 week and 48 week
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Dita Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing You An Hospital, Capital Medical University
state: Beijing
city: Changsha
country: China
facility: The First Hospital of Changsha
state: Hunan
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Kunming
country: China
facility: Yun Provincial Infectious Disease Hospital
state: Yunnan
city: Hangzhou
country: China
facility: Xixi Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Tianjin
country: China
facility: Tianjin Second People's Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Taisheng Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: