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

• Status: Unknown status
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College
• Collaborator: Ministry of Science and Technology of the People´s Republic of China
• Treatments: Lamivudine; Lopinavir; Raltegravir Potassium; Ritonavir; Tenofovir; Triptolide

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