drugset / Trial / NCT02002286
Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-08
- Primary completion
- 2013-05
- Completion
- 2013-05
Publications
- 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.
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tripterygium Wilfordii Hook F extract | Traditional medicine (herbal / TCM) | 10 mg | Oral |
| Background | Efavirenz | Other / unclassified | — | — |
| Background | Lamivudine | Other / unclassified | — | — |
| Background | Nevirapine | Small molecule | — | — |
| Background | Stavudine | Other / unclassified | — | — |
| Background | Zidovudine | Small molecule | — | — |