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.

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.