NCT03403569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
353

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2018

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2020

Enrollment Period

2.8 years

First QC Date

January 11, 2018

Last Update Submit

March 31, 2022

Conditions

HIV-infection/AIDS

Keywords

CD4 cell recoveryimmune activationanti-inflammation

Outcome Measures

Primary Outcomes (1)

  • CD4 T cell counts and HIV RNA

    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.

    Baseline, Week4, Week12, Week24, Week36, Week 48

Secondary Outcomes (3)

  • Immune activation

    Baseline, Week4, Week12, Week24, Week36, Week 48

  • Inflammation level

    Baseline, Week4, Week12, Week24, Week36, Week 48

  • HIV reservoir

    Baseline, Week4, Week12, Week24, Week36, Week 48

Study Arms (2)

Triptolide Wilfordii Group

EXPERIMENTAL

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

Placebo Oral Tablet Group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

Triptolide WilfordiiDRUG

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.

Triptolide Wilfordii Group
Placebo Oral TabletDRUG

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.

Placebo Oral Tablet Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 350025, China

Location

The Eighth People's Hospital of Guangzhou

Guangzhou, Guangdong, 510060, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

The Sixth People's Hospital of Zhengzhou

Zhengzhou, Henan, 450015, China

Location

Xixi Hospital of Hangzhou

Hangzhou, Zhejiang, 310023, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, 100069, China

Location

Beijing Ditan Hospital, Capital Medical University

Beijing, 100191, China

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Wei Lyu

    Department of Infectious Diseases, PekingUMCH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

September 1, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

April 8, 2022

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(7)