Status:
UNKNOWN
Study on the Impact of Triptolide Woldifiion on HIV-1 Reservoir In Acute HIV-1 Infection
Lead Sponsor:
Peking Union Medical College
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
AIDS/HIV PROBLEM
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
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 la...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2017
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02219672
Start Date
July 1 2014
End Date
July 1 2017
Last Update
August 19 2014
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730