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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Drug: Tripterygium Wilfordii Hook F extract (TwHF extract); Drug: cART

• Registration Number: NCT02002286
• Lead Sponsor: LI Taisheng

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.

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-11
• Study First Submitted: 2013-11-18
• Study First Submitted QC: 2013-11-29
• Last Update Submitted: 2013-11-29
• Study First Posted: 2013-12-05
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TwHF extract + cART	Tripterygium Wilfordii Hook F extract (TwHF extract)	Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
TwHF extract + cART	cART	Use Tripterygium Wilfordii Hook F extract (TwHF extract) and continue current cART regimen
cART control	cART	Continue current cART regimen

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Viral load	12 months	During follow-up, viral load will also be monitored.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China