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

Shanghai Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Abnormal Immune Activation in HIV/AIDS

Treatments: Drug: Placebo; Drug: T8 tablet 0.5mg; Drug: T8 tablet 1mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04084444

T8-201

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 3 patient groups, including a placebo group

T8 tablet 0.5mg

Experimental group

Description:

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

Treatment:

Drug: T8 tablet 0.5mg

T8 tablet 1mg

Experimental group

Description:

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

Treatment:

Drug: T8 tablet 1mg

Placebo

Placebo Comparator group

Description:

Oral Placebo with HARRT, once daily for 48 week

Treatment:

Drug: Placebo