A Phase 2 interventional study of T8 tablet 0.5mg and T8 tablet 1mg in Chronic Abnormal Immune Activation in HIV/AIDS, sponsored by Shanghai Pharmaceuticals Holding Co., Ltd. Completed at 9 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-31.
Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd · Phase 2, Interventional, and Treatment
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.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 151 is above the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Shanghai Pharmaceuticals Holding Co., Ltd is the lead sponsor of 35 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week
Drug: T8 tablet 0.5mg
Oral T8 tablet with HARRT, 1mg, once daily for 48 week
Drug: T8 tablet 1mg
Oral Placebo with HARRT, once daily for 48 week
Drug: Placebo
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
Also known as: Leiteng Shu
Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
Also known as: Leiteng Shu
Blank control.
CD4+ T lymphocyte count
The changes of CD4+ T lymphocyte count from baseline
Time frame: 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
Time frame: 48 week
The changes of inflammatory factors
The quantitative changes of inflammatory factors（IP-10、hsCRP、IL-6）from baseline
Time frame: 48 week
CD4+/CD8+T lymphocyte ratio
The changes of CD4+/CD8+T lymphocytes from baseline
Time frame: 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
Time frame: 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.
Time frame: 24 week and 48 week
Incidence of AE and SAE
The incidence of AE and SAE
Time frame: 24 week and 48 week
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
Time frame: 24 week and 48 week
Plan to share: Undecided
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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
Shanghai Pharmaceuticals Holding Co., Ltd