HIV
Conditions
Keywords
HIV-infected immunological non-responders, Tripterygium Wilfordii Hook F, Immune activation
Brief summary
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
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.
Interventions
DRUGcART
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.
DRUGTripterygium 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.
Sponsors
LI Taisheng
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of T cell subsets and immune activation markers | 12 months | T cell subsets and activation biomarkers including CD4 count, memory and naive CD4 cell count, and CD38/HLA-DR expression will be monitored. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral load | 12 months | During follow-up, viral load will also be monitored. |
| Number of participants with adverse events as a measure of safety and tolerability | 12 months | During each follow-up time point, clinical status and adverse effects will also be evaluated. |
Countries
China
Outcome results
None listed