Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses

Overview

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.

Full Title of Study: “Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2013

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.

Interventions

  • Drug: 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.
  • Drug: 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.

Arms, Groups and Cohorts

  • Experimental: TwHF extract + cART
    • Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
  • Other: cART control
    • Continue current cART regimen

Clinical Trial Outcome Measures

Primary Measures

  • Changes of T cell subsets and immune activation markers
    • Time Frame: 12 months
    • T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored.

Secondary Measures

  • Viral load
    • Time Frame: 12 months
    • During follow-up, viral load will also be monitored.
  • Number of participants with adverse events as a measure of safety and tolerability
    • Time Frame: 12 months
    • During each follow-up time point, clinical status and adverse effects will also be evaluated.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LI Taisheng
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: LI Taisheng, Professor – Peking Union Medical College
  • Overall Official(s)
    • Taisheng Li, MD, PhD, Principal Investigator, Department of Infectious Diseases, Peking Union Medical College Hospital

References

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.

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