A Phase 3 interventional study of Triptolide Wilfordii and Placebo Oral Tablet in HIV-infection/AIDS, sponsored by Peking Union Medical College Hospital. Completed at 7 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Peking Union Medical College Hospital · Phase 3, Interventional, and Treatment
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Among 87 studies in Acquired Immunodeficiency Syndrome with a site in China — 22 open to participants now, 24 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · China.
Among the 87 studies in Acquired Immunodeficiency Syndrome with a site in China, this one is the 17th largest by enrollment of the 68 interventional ones that give a count, is one of 7 that started in 2018, is one of 7 in phase 3, and was the 34th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →22 of the 87 studies in Acquired Immunodeficiency Syndrome with a site in China are open now. Recruiting first, the newest first:
Jiangsu Aidea Pharmaceutical Group Co., Ltd. · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 40+
Cell Energy Life Sciences Group Co. LTD · Sites in China
Ages 18–65
Guangzhou 8th People's Hospital · Sites in China
Ages 18–65
Guangzhou 8th People's Hospital · Sites in China
Ages 18–65
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
87 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 16 · Phase 3 7 · Phase 4 4
First in 2005; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 353 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 108 across the 68 interventional studies, 400 across the 18 observational. Of the 33 that completed or were terminated, 7 (21%) have results posted.
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23 of 87 have an industry lead sponsor. The 10 most frequent:
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Peking Union Medical College Hospital has 6 studies filed under Acquired Immunodeficiency Syndrome — fewer than ten, so there is no comparison to draw.
4 of the studies in Acquired Immunodeficiency Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07519538Southwest Medical UniversitySouthern Sichuan HIV Cohort Study Protocol | 2027-04-30 |
| NCT07577986First Affiliated Hospital of Zhejiang UniversityA Safety and Efficacy Trial of Chidamide Combined With NKG2D CAR-NK Cell Therapy for Reducing the HIV Viral Reservoir | 2027-05-01 |
| NCT07711210Jiangsu Aidea Pharmaceutical Group Co., Ltd.Efficacy and Safety of the ACC017-Based Antiretroviral Regimen in Treatment-Experienced Adults With HIV-1 Harboring Non-Nucleoside Reverse Transcriptase Inhibitor Resistance Mutations | 2027-06-30 |
| NCT05939167Cell Energy Life Sciences Group Co. LTDMesenchymal Stem Cells Treatment for AIDS Patients at Late Stage | 2027-07-10 |
Add all 4 to your calendar (.ics) → With an account.
Among the 87 studies in Acquired Immunodeficiency Syndrome with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that immunosuppression therapy has recently become a new strategy for HIV infection, it's reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients. So we designed a randomized, double-blinded, placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.
Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular, renal, hepatic diseases. Recently, immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders, who were defined as patients with CD4 cell counts\<350 cells/μl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve HIV infection. This randomized, double-blinded, placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
150 patients will be enrolled and be administrated with Triptolide Wilfordii 20mg three times a day(TID) per os combined with appropriate ART for 12 months.
Drug: Triptolide Wilfordii
150 patients will be enrolled and be administrated with placebo per os combined with appropriate ART for 12 months.
Drug: Placebo Oral Tablet
In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.
In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.
CD4 T cell counts and HIV RNA
Compared to patients in placebo group, CD4 T cells of patients treated with Triptolide Wilfordii significantly increase and HIV RNA is reduced below 20 copies/ml.
Time frame: Baseline, Week4, Week12, Week24, Week36, Week 48
Immune activation
Compared to patients in placebo group, immune activation index of patients treated with Triptolide Wilfordii decreases.
Time frame: Baseline, Week4, Week12, Week24, Week36, Week 48
Inflammation level
Compared to patients in placebo group, inflammation level of patients treated with Triptolide Wilfordii decreases.
Time frame: Baseline, Week4, Week12, Week24, Week36, Week 48
HIV reservoir
Compared to patients in placebo group, HIV reservoir of patients treated with Triptolide Wilfordii is reduced.
Time frame: Baseline, Week4, Week12, Week24, Week36, Week 48
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2018 to primary completion in Jun 2021, 33 months.
Of 31 non-industry phase 3 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 51. This study's 33 months is close to that.
Counting every sponsor, half of 65 studies reached it within 26 months; a quarter within 19 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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