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

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.

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