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This study is a pilot study to evaluate impact of Tripterygium Wilfordii Hook F (TwHF) on T cell immune activation and immune activation in HIV-infected immunological non-responders. The investigators aim to evaluate the safety and efficacy profiles of TwHF in HIV immunological non-responders.
The investigators recruited 23 patients from Peking Union Medical College Hospital Outpatient clinic. They were all immunological non-responders. Nineteen patients will receive Triptolide wilfordii Hook F extract (10mg tid po) plus current cART, while 4 patients will continue their current cART. This study will last for 12 months. Patients will be followed up at month 0, 3, 6, 9, and 12. During each follow-up time point, adverse effects, T cell subsets, T cell activation markers and other routine tests will be ordered. The investigators hypothesis that TwHF might boost CD4 cell recovery by reducing immune activation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TwHF extract + cART | Experimental | Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen |
|
| cART control | Other | Continue current cART regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tripterygium Wilfordii Hook F extract (TwHF extract) | Drug | The extract Tripterygium wilfordii Hook F (TwHF), a traditional Chinese medication, has been used as anti-inflammatory therapy to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of T cell subsets and immune activation markers | T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | During follow-up, viral load will also be monitored. | 12 months |
| Number of participants with adverse events as a measure of safety and tolerability | During each follow-up time point, clinical status and adverse effects will also be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisheng Li, MD, PhD | Department of Infectious Diseases, Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100730 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21576701 | Background | Piconi S, Parisotto S, Rizzardini G, Passerini S, Terzi R, Argenteri B, Meraviglia P, Capetti A, Biasin M, Trabattoni D, Clerici M. Hydroxychloroquine drastically reduces immune activation in HIV-infected, antiretroviral therapy-treated immunologic nonresponders. Blood. 2011 Sep 22;118(12):3263-72. doi: 10.1182/blood-2011-01-329060. Epub 2011 May 16. | |
| 20844049 |
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| ID | Term |
|---|---|
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| cART | Drug | Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz. |
|
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| 12 months |
| Murray SM, Down CM, Boulware DR, Stauffer WM, Cavert WP, Schacker TW, Brenchley JM, Douek DC. Reduction of immune activation with chloroquine therapy during chronic HIV infection. J Virol. 2010 Nov;84(22):12082-6. doi: 10.1128/JVI.01466-10. Epub 2010 Sep 15. |
| 25874991 | Derived | Li T, Xie J, Li Y, Routy JP, Li Y, Han Y, Qiu Z, Lv W, Song X, Sun M, Zhang X, Wang F, Jiang H. Tripterygium wilfordii Hook F extract in cART-treated HIV patients with poor immune response: a pilot study to assess its immunomodulatory effects and safety. HIV Clin Trials. 2015 Mar-Apr;16(2):49-56. doi: 10.1179/1528433614Z.0000000005. Epub 2015 Jan 26. |