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

November 18, 2013
November 29, 2013
August 2011
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02002286 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of TwHF in HIV Patients With Poor Immune Responses
Pilot Study: Safety and Efficacy Study of Tripterygium Wilfordii Hook F Extract in cART-Treated HIV Patients With Poor Immune Responses

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV
  • 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
  • Experimental: TwHF extract + cART
    Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
    Interventions:
    • Drug: Tripterygium Wilfordii Hook F extract (TwHF extract)
    • Drug: cART
  • cART control
    Continue current cART regimen
    Intervention: Drug: cART

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT02002286
TwHF Pilot
Yes
LI Taisheng, Peking Union Medical College
LI Taisheng
Not Provided
Principal Investigator: Taisheng Li, MD, PhD Department of Infectious Diseases, Peking Union Medical College Hospital
Peking Union Medical College
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP