Status:
UNKNOWN
Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients
Lead Sponsor:
Peking Union Medical College
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
Acquired Immune Deficiency Syndrome
HIV Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. This study aims to set up a well-trained clinical and lab...
Detailed Description
Three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3TC+D4T+NVP or AZT+3TC+NVP, 6 months later half of the 3TC+D4T+NVP...
Eligibility Criteria
Inclusion
- age between 18-65 years
- HIV seropositive and confirmed by western blot
- antiretroviral therapy naive for arm 1
- CD4 cell count \< 350/mm3
- good adherence and follow up in the same place
Exclusion
- pregnancy and breastfeeding
- AIDS defining illness or any infectious disease occured in one month but still unstable within 14 days
- with WBC \< 2000/ul, neutrophil count \< 1000/ul, hemoglobin \< 9 g/dl, platelet count \< 75000/ul, amylase \> 2 ULN, transaminase or alkaline phosphatase or total bilirubin \> 2 ULN, creatinine \> 2 ULT.
- present acute or chronic pancreatitis
- intravenous drug user
- peripheral nephropathy
- severe nephropathy or mental disorder
- severe gastral ulcer
- heart or brain arthrosclerosis
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00872417
Start Date
March 1 2009
End Date
December 1 2010
Last Update
March 31 2009
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730