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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T8 tablet 0.5mg | Experimental | Oral T8 tablet with HARRT, 0.5mg, once daily for 48 week |
|
| T8 tablet 1mg | Experimental | Oral T8 tablet with HARRT, 1mg, once daily for 48 week |
|
| Placebo | Placebo Comparator | Oral Placebo with HARRT, once daily for 48 week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T8 tablet 0.5mg | Drug | Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| CD4+ T lymphocyte count | The changes of CD4+ T lymphocyte count from baseline | 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 | 48 week |
| The changes of inflammatory factors | The quantitative changes of inflammatory factors(IP-10、hsCRP、IL-6)from baseline | 48 week |
| Measure | Description | Time Frame |
|---|---|---|
| CD4+/CD8+T lymphocyte ratio | The changes of CD4+/CD8+T lymphocytes from baseline | 24 week and 48 week |
| The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 week and 48 week |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisheng Li, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100032 | China | ||
| Beijing Dita Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37283977 | Derived | Cao W, Liu X, Han Y, Song X, Lu L, Li X, Lin L, Sun L, Liu A, Zhao H, Han N, Wei H, Cheng J, Zhu B, Wang M, Li Y, Ma P, Gao L, Wang X, Yu J, Zhu T, Routy JP, Zuo M, Li T. (5R)-5-hydroxytriptolide for HIV immunological non-responders receiving ART: a randomized, double-blinded, placebo-controlled phase II study. Lancet Reg Health West Pac. 2023 Mar 15;34:100724. doi: 10.1016/j.lanwpc.2023.100724. eCollection 2023 May. |
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| T8 tablet 1mg | Drug | Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation. |
|
|
| Placebo | Drug | Blank control. |
|
The proportion of subjects whose CD4+ T lymphocyte count is increased by ≥20% from baseline
| 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. | 24 week and 48 week |
| Incidence of AE and SAE | The incidence of AE and SAE | 24 week and 48 week |
| Beijing |
| Beijing Municipality |
| China |
| Beijing You An Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| The First Hospital of Changsha | Changsha | Hunan | China |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | China |
| Yun Provincial Infectious Disease Hospital | Kunming | Yunnan | 650399 | China |
| Xixi Hospital of Hangzhou | Hangzhou | Zhejiang | 310023 | China |
| The First Affiliated Hospital, Zhejiang University | Hangzhou | Zhejiang | China |
| Tianjin Second People's Hospital | Tianjin | China |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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