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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-25

Study Completion Date

2022-07-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Abnormal Immune Activation in HIV/AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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T8 tablet 0.5mg

Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week

Group Type EXPERIMENTAL

T8 tablet 0.5mg

Intervention Type DRUG

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

T8 tablet 1mg

Oral T8 tablet with HARRT, 1mg, once daily for 48 week

Group Type EXPERIMENTAL

T8 tablet 1mg

Intervention Type DRUG

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Placebo

Oral Placebo with HARRT, once daily for 48 week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Blank control.

Interventions

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T8 tablet 0.5mg

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Intervention Type DRUG

T8 tablet 1mg

Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.

Intervention Type DRUG

Placebo

Blank control.

Intervention Type DRUG

Other Intervention Names

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Leiteng Shu Leiteng Shu

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No