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Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection

Primary Purpose

AIDS/HIV PROBLEM

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Triplitode
Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
Sponsored by
Peking Union Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for AIDS/HIV PROBLEM focused on measuring Triptolide wilfordii HIV-1 reservoir acute hiv infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • age between 18-65 years

    • HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection
    • good adherence and follow up in the same place
    • Inform Consent signed
    • ART-naïve

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

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Triptolide group

Comparator group

Arm Description

cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months

combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months

Outcomes

Primary Outcome Measures

Changes of the immunologic response, virologic response, and hiv-1 reservoir

Secondary Outcome Measures

Adverse events of the therapy

Full Information

First Posted
August 16, 2014
Last Updated
August 18, 2014
Sponsor
Peking Union Medical College
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT02219672
Brief Title
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection
Official Title
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking Union Medical College
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a prospective trial which will recruit 18 patients in acute HIV-1 infection phase. This study aims to evaluate the effects and side effects of ARV treatment in Chinese patients in acute HIV-1 infection phase, and to evaluate the impact of Triptolide wilfordii on HIV-1 reservoir.
Detailed Description
Two arms will be enrolled in this study, 18 naive-treatment Chinese patients in acute HIV-1 infection phase would be allocated to two arms, and treated with the antiretroviral drugs (Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir). Six months later, 12 patients will be treated with Triplitode, in order to observe the impact of of Triptolide wilfordii on HIV-1 reservoir of patients in acute infection phase. All patients should be explored for 18 months in terms of the clinical features, drugs side-effects, and immunological and viral response, and the HIV-1 reservoir. We hypothesis that Triptolide wilfordii might further reduce the HIV-1 reservoir. The result would provide proofs for further practical antiviral therapy for patients in acute infection phase in China or other resource limited countries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS/HIV PROBLEM
Keywords
Triptolide wilfordii HIV-1 reservoir acute hiv infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Triptolide group
Arm Type
Experimental
Arm Description
cART for 6 months, and the experimental group will take Triplitode 2 tabs tid po for another 12 months
Arm Title
Comparator group
Arm Type
Active Comparator
Arm Description
combined antiretroviral therapy (cART): TDF+3TC+LPV/r+RAL for 18 months
Intervention Type
Drug
Intervention Name(s)
Triplitode
Other Intervention Name(s)
Triptolide Wilfordii
Intervention Description
Drug: Triptolide 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. Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir .
Intervention Type
Drug
Intervention Name(s)
Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir
Other Intervention Name(s)
TDF+3TC+LPV/r+RAL for 18 months
Intervention Description
Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.
Primary Outcome Measure Information:
Title
Changes of the immunologic response, virologic response, and hiv-1 reservoir
Time Frame
baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits
Secondary Outcome Measure Information:
Title
Adverse events of the therapy
Time Frame
thirty-six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • age between 18-65 years HIV seropositive and confirmed by western blot, confirmed as acute HIV-1 infection good adherence and follow up in the same place Inform Consent signed ART-naïve 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Lv, MD
Phone
8610-69155046
Email
lvweipumch@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fuping Guo, MD
Phone
8610-69155046
Email
pumchguofp@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taisheng Li, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuping Guo, MD
Phone
86-10-69155082
Email
pumchguofp@163.com
First Name & Middle Initial & Last Name & Degree
Taisheng Li, PhD

12. IPD Sharing Statement

Learn more about this trial

Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection

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