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

AIDS/HIV PROBLEM Clinical Trial

Official title:

Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir of Chinese HIV/AIDS Patients In Acute HIV-1 Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02219672
• Other study ID #: CACT140816
• Status: Recruiting
• Phase: Phase 3
• First received: August 16, 2014
• Last updated: August 18, 2014
• Start date: July 2014
• Est. completion date: July 2017

Study information

• Verified date: August 2014
• Source: Peking Union Medical College
• Contact: Wei Lv, MD
• Phone: 8610-69155046
• Email: lvweipumch[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS/HIV PROBLEM

Intervention

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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College	Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Adverse events of the therapy		thirty-six months	Yes