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

N/ACompletedNCT02002286

LI Taisheng23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV

Interventions

Tripterygium Wilfordii Hook F extract (TwHF extract)DRUG

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.

cARTDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, China

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

Viral load

During follow-up, viral load will also be monitored.

Time frame: 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.

Time frame: 12 months

Data from ClinicalTrials.gov

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