Status:
COMPLETED
Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
Lead Sponsor:
Peking Union Medical College
Collaborating Sponsors:
Ministry of Science and Technology of the People´s Republic of China
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether the three generic nevirapine-based antiretroviral regimens are effective in the treatment of Acquired immune deficiency syndrome .
Eligibility Criteria
Inclusion
- 18 years or older
- the subjects were HIV-seropositive by standard serum enzyme-linked immunosorbent assay (ELISA) tests and also by Western blot analysis
- the subjects were antiretroviral drug-naïve
- a baseline CD4+ T-cell count from 100 to 350 cells/mm3 and a baseline plasma viral load over 500copies/ml
Exclusion
- pregnancy or breastfeeding
- anticipated nonadherence
- AIDS-defining illness within 2 weeks of entry
- white blood cell count less than 2.0×109/L, absolute neutrophil count less than 1.0×109/L, hemoglobin level less than 90g/l, platelet count less than 0.75×1012/L
- transaminase and alkaline phosphatase level more than 3 times the upper limit of the normal range, bilirubin level more than 2.5times the upper limit of the normal range, serum creatinine level more than 1.5 times the upper limit of the normal range
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00618176
Start Date
January 1 2005
Last Update
March 24 2008
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730