Overview

Study on the Antiviral Therapy and Immune Reconstitution of Chinese HIV/AIDS Patients

Status:
Unknown status
Trial end date:
2010-12-01
Target enrollment:
0
Participant gender:
All
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 laboratory team in China, to explore the effects and side-effects of the first-line and the second line of ARV treatment in Chinese HIV/AIDS adult patients, to investigate the side-effects of ARV drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (PK/PD) of Chinese generic ARV regiments and effective drug concentrations and to explore primary and secondary drug resistance in China and the immune reconstitution characters of long term ARV in Chinese adult AIDS patients. This study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.
Phase:
Phase 4
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
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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