Clinical trial NCT02002286: Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses
Official title: Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV-infected immunological non-responders
Tripterygium Wilfordii Hook F
Immune activation
Lead sponsor: Peking Union Medical College
Sponsor class: OTHER
First posted: 2013-12-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Continuous antiretroviral therapy \> 18 months, and consistent HIV-RNA\< 40 copies/mL more than 12 months;
* 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:

* Active opportunistic infection (not stable within 4 weeks 2 weeks ) or AIDS-related carcinoma;
* 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

Primary outcomes:
measure: Changes of T cell subsets and immune activation markers
timeFrame: 12 months
Secondary outcomes:
measure: Viral load
timeFrame: 12 months
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Department of Infectious Diseases, Peking Union Medical College Hospital
name: Taisheng Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.