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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV

Intervention / Treatment
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* Drug: Tripterygium Wilfordii Hook F extract (TwHF extract)
* Drug: cART


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TwHF extract + cART<br>Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen | Drug: Tripterygium Wilfordii Hook F extract (TwHF extract)<br>* 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.<br>* Other names: Triptolide Wilfordii;Drug: cART<br>* 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.<br>* Other names: Combination antiretroviral therapy;|
| Other: cART control<br>Continue current cART regimen | Drug: cART<br>* 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.<br>* Other names: Combination antiretroviral therapy;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV-infected immunological non-responders, Tripterygium Wilfordii Hook F, Immune activation