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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014