NCT01817283

Brief Summary

This study is a prospective, multicenter, randomized, placebo-controlled clinical trial, to evaluate impact of Triptolide wilfordii on T cell immune activation and inflammation biomarkers in HIV-infected immunological non-responders.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1 hiv

Timeline
Completed

Started Jan 2013

Typical duration for phase_1 hiv

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 25, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

March 18, 2013

Last Update Submit

March 22, 2013

Conditions

HIV

Keywords

HIV-infected immunological non-respondersTriptolideimmune activationinflammationCD4 T cell

Outcome Measures

Primary Outcomes (1)

  • Changes of T cell immune activation and inflammation biomarkers

    T cell activation and inflammatory biomarkers including CD8+HLA-DR+/CD38+, IL-6, D-dimer and hsCRP,soluble CD14 and CD163, PD-1, CCR5 and CD57 should be measured at baseline and at Wee4, W12, W24, W36, W48 follow-up visits.

    baseline and at 4,8,12,24,36,48 weeks

Secondary Outcomes (1)

  • Changes of CD4 T cell count and number of participants with adverse events

    baseline and at 4,8,12,24,36,48 weeks

Study Arms (2)

placebo + cART

PLACEBO COMPARATOR

combined with antiretroviral therapy, the control group will take placebo 2 tabs tid per day lasting for 6 months and then switch to take Triplitode 2 tabs tid po for anther 6 months

Drug: TriptolideDrug: cARTDrug: placebo

Triptolide + cART

EXPERIMENTAL

combined antiretroviral therapy, the experimental group will take Triptolide 2 tabs tid po per day for 12 months.

Drug: TriptolideDrug: cART

Interventions

TriptolideDRUG

Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.

Also known as: Tripterygium Wilfordii Hook F (TwHF)
Triptolide + cARTplacebo + cART
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.

Also known as: Antiretroviral therapy
Triptolide + cARTplacebo + cART
placeboDRUG

Placebo pills produced the same as Triptolide wilfordii.

Also known as: sugar pills
placebo + cART

Eligibility Criteria

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

You may qualify if:

  • Continuous antiretroviral therapy \> 24 months ， and consistent HIV-RNA\< 40 copies/mL more than 12 months ;
  • years old;
  • Male or female;
  • Good adherence and promise to follow-up;
  • Inform Consent signed;
  • CD4 T cells less than 250/ul .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Inflammation

Interventions

triptolideAntiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Study Officials

  • Tai sheng LI, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei LU, M.D.

CONTACT

00861069155081lvweipumch@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Peking Union Medical College Hospital

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 25, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

March 1, 2015

Last Updated

March 25, 2013

Record last verified: 2013-03

Locations

CN(1)