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

NCT02219672 | Unknown Phase 3 DMC

• 1 other identifier: CACT140816
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS/HIV PROBLEM

Keywords

Triptolide wilfordii HIV-1 reservoir acute hiv infection

Outcome Measures

Primary Outcomes (1)

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

  baseline and at Week 4, Week 12, Week 24, Week 36 follow-up visits

Secondary Outcomes (1)

• Adverse events of the therapy

  thirty-six months

Study Arms (2)

Triptolide group

EXPERIMENTAL

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

Drug: Triplitode

Comparator group

ACTIVE COMPARATOR

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

Drug: Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir

Interventions

Triplitode DRUG

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 .

Also known as: Triptolide Wilfordii

Triptolide group

Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir DRUG

Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.

Also known as: TDF+3TC+LPV/r+RAL for 18 months

Comparator group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Peking Union Medical College: lead
• Ministry of Science and Technology of the People´s Republic of China: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Interventions

Tenofovir; Lamivudine; Lopinavir; Ritonavir; Raltegravir Potassium

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides; Pyrimidinones; Thiazoles; Sulfur Compounds; Azoles; Pyrrolidinones; Pyrrolidines

Study Officials

• Taisheng Li, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Lv, MD

CONTACT

8610-69155046; lvweipumch@163.com

Fuping Guo, MD

CONTACT

8610-69155046; pumchguofp@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department of the infectious disease

Study Record Dates

• First Submitted: August 16, 2014
• First Posted: August 19, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2017
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

CN (1)