Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses
NCT ID: NCT02002286
Last Updated: 2013-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2011-08-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TwHF extract + cART
Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
Tripterygium Wilfordii Hook F extract (TwHF extract)
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.
cART
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.
cART control
Continue current cART regimen
cART
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.
Interventions
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Tripterygium Wilfordii Hook F extract (TwHF extract)
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.
cART
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-65 years old;
* Male or female;
* Good adherence and promise to follow-up;
* Inform Consent signed;
* CD4 T cells less than 300/ul .
Exclusion Criteria
* Hemoglobin (HGB) \< 9 g/dl, white blood cell (WBC) \< 2000/ul, granulin (GRN) \< 1000 /ul, platelet (PLT) \< 75000 /ul, Cr \>1.5x ULN, ALT or AST or alkaline phosphatase (ALP) \>3x upper limit of normal (ULN), total bilirubin (TBIL) \>2x ULN, creatine kinase (CK) \> 2x ULN;
* Pregnant or breastfeeding woman or woman with pregnancy plan;
* Active drug-user;
* Severe neurological defects;
* Active alcohol abuse;
* Severe gastrointestinal ulcer .
* End-stage disease such as cirrhosis, chronic obstructive pulmonary disease, congestive heart failure, recent myocardial ischemia,tumor, etc Those who are undertaking steroids, immunomodulator, anti-inflammatory agents
18 Years
65 Years
ALL
No
Sponsors
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LI Taisheng
OTHER
Responsible Party
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LI Taisheng
Professor
Principal Investigators
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Taisheng Li, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases, Peking Union Medical College Hospital
Locations
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Peking Union Medical College Hospital
Beijing, , China
Countries
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References
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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.
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.
Other Identifiers
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TwHF Pilot
Identifier Type: -
Identifier Source: org_study_id