Safety and Efficacy of Triptolide Wilfordii in New Onset HIV-1 Infection

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03403569
Collaborator
(none)
353
7
2
33.9
50.4
1.5

Study Details

Study Description

Brief Summary

The traditional Chinese herbal medicine Triptolide Wilfordii has displayed remarkable effect on the treatment of autoimmune diseases such as rheumatoid arthritis. Now that immunosuppression therapy has recently become a new strategy for HIV infection, it's reasonable to expect the anti-inflammatory effect of Triptolide Wilfordii in HIV infected patients. So we designed a randomized, double-blinded, placebo-controlled study to explore the efficacy and safety of Triptolide Wilfordii in new-onset HIV infection.

Condition or Disease Intervention/Treatment Phase
  • Drug: Triptolide Wilfordii
  • Drug: Placebo Oral Tablet
Phase 3

Detailed Description

Acquired immune deficiency syndrome(AIDS) is a severe fatal disease caused by HIV infection. Despite viral suppression achieved, antiretroviral therapy(ART) cannot ameliorate HIV-induced immune activation and the consequent non-AIDS complications including cardiovascular, renal, hepatic diseases. Recently, immunosuppression therapy has become the focus since it can suppress exorbitant immune activation and inflammation so as to reduce the risk of non-AIDS cardiovascular and central neural system complications. Triptolide Wilfordii is a traditional Chinese herbal remedy and has long been used in the treatment of autoimmune diseases such as rheumatoid arthritis. Moreover, a recent study has shown that Triptolide Wilfordii combined with ART is associated with increased CD4 T cell counts and reduced immune activation in immunological non-responders, who were defined as patients with CD4 cell counts<350 cells/μl despite over 2 years of ART. Hence we expect Triptolide Wilfordii to bring up similar improvement in treatment naïve HIV infection. This randomized, double-blinded, placebo-controlled study is designed to investigate the safety and efficacy of Triptolide Wilfordii and hopefully provide evidence for a new treatment strategy.

Study Design

Study Type:
Interventional
Actual Enrollment :
353 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Triptolide Wilfordii on Viral Suppression, Immune Recovery and Immune Activation Biomarkers in Treatment-naive HIV-1 Infection: a Randomized, Double-blinded, Placebo-controlled Study
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Triptolide Wilfordii Group

150 patients will be enrolled and be administrated with Triptolide Wilfordii 20mg three times a day(TID) per os combined with appropriate ART for 12 months.

Drug: Triptolide Wilfordii
In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.

Placebo Comparator: Placebo Oral Tablet Group

150 patients will be enrolled and be administrated with placebo per os combined with appropriate ART for 12 months.

Drug: Placebo Oral Tablet
In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.

Outcome Measures

Primary Outcome Measures

  1. CD4 T cell counts and HIV RNA [Baseline, Week4, Week12, Week24, Week36, Week 48]

    Compared to patients in placebo group, CD4 T cells of patients treated with Triptolide Wilfordii significantly increase and HIV RNA is reduced below 20 copies/ml.

Secondary Outcome Measures

  1. Immune activation [Baseline, Week4, Week12, Week24, Week36, Week 48]

    Compared to patients in placebo group, immune activation index of patients treated with Triptolide Wilfordii decreases.

  2. Inflammation level [Baseline, Week4, Week12, Week24, Week36, Week 48]

    Compared to patients in placebo group, inflammation level of patients treated with Triptolide Wilfordii decreases.

  3. HIV reservoir [Baseline, Week4, Week12, Week24, Week36, Week 48]

    Compared to patients in placebo group, HIV reservoir of patients treated with Triptolide Wilfordii is reduced.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18~65 years old;

  • Male or female;

  • Good adherence and promise to follow-up;

  • Inform Consent signed;

  • Positive for HIV antibody test or serum HIV-RNA positive for 2 times or more;

Exclusion Criteria:
  • Present opportunity infection defined according to national AIDS treatment guideline or active opportunistic infection(not stable within 14 days ) within 3 months before recruitment or AIDS-related carcinoma;

  • Hemoglobin (HGB) < 9 g/dl, white blood cell (WBC) < 3000/ul, granulin (GRN) < 1500 /ul, platelet (PLT) < 75000 /ul, Cr >1.5x upper limit of normal (ULN), ALT or AST or alkaline phosphatase (ALP) >3x ULN, total bilirubin (TBIL) >2x ULN;

  • Pregnancy or breastfeeding;

  • Woman with pregnancy plan;

  • Severe organ dysfunction;

  • Administration of immunosuppressor, immunomodulator(including thymocin) or systemic cytotoxic drugs within 6 months before recruitment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mengchao Hepatobiliary Hospital of Fujian Medical University Fuzhou Fujian China 350025
2 The Eighth People's Hospital of Guangzhou Guangzhou Guangdong China 510060
3 The Fourth Affiliated Hospital of Harbin Medical University Harbin Heilongjiang China 150001
4 The Sixth People's Hospital of Zhengzhou Zhengzhou Henan China 450015
5 Xixi Hospital of Hangzhou Hangzhou Zhejiang China 310023
6 Beijing YouAn Hospital, Capital Medical University Beijing China 100069
7 Beijing Ditan Hospital, Capital Medical University Beijing China 100191

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Wei Lyu, Department of Infectious Diseases, PekingUMCH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03403569
Other Study ID Numbers:
  • PekingUMCH record JS-985
First Posted:
Jan 18, 2018
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Peking Union Medical College Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022