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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LI Taisheng, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT02002286
First received: November 18, 2013
Last updated: November 29, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
HIV
Drug: Tripterygium Wilfordii Hook F extract (TwHF extract)
Drug: cART

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • Changes of T cell subsets and immune activation markers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored.


Secondary Outcome Measures:
  • Viral load [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    During each follow-up time point, clinical status and adverse effects will also be evaluated.


Enrollment: 23
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TwHF extract + cART
Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
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.
Other Name: Triptolide Wilfordii
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.
Other Name: Combination antiretroviral therapy
cART control
Continue current cART regimen
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.
Other Name: Combination antiretroviral therapy

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02002286

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
LI Taisheng
Investigators
Principal Investigator: Taisheng Li, MD, PhD Department of Infectious Diseases, Peking Union Medical College Hospital
  More Information

Publications:
Responsible Party: LI Taisheng, Professor, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT02002286     History of Changes
Other Study ID Numbers: TwHF Pilot
Study First Received: November 18, 2013
Last Updated: November 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College:
HIV-infected immunological non-responders
Tripterygium Wilfordii Hook F
Immune activation

ClinicalTrials.gov processed this record on April 16, 2014