Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort - Tabular View

Tracking Information
First Received Date ^ICMJE	February 5, 2008
Last Updated Date	March 21, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date	September 2006 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00618176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
Official Title ^ICMJE
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 .
Detailed Description
Study Phase	Phase IV
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Parallel Assignment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP) Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
Study Arms / Comparison Groups
Publications *	Li T, Dai Y, Kuang J, Jiang J, Han Y, Qiu Z, Xie J, Zuo L, Li Y. Three generic nevirapine-based antiretroviral treatments in Chinese HIV/AIDS patients: multicentric observation cohort. PLoS ONE. 2008;3(12):e3918. Epub 2008 Dec 12.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	198
Completion Date
Primary Completion Date	September 2006 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Criteria: 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT ID ^ICMJE	NCT00618176
Responsible Party	Taisheng Li, Peking Union Medical College Hospital
Study ID Numbers ^ICMJE	2004BA719A10, 2004BA719A10
Study Sponsor ^ICMJE	Peking Union Medical College
Collaborators ^ICMJE	Ministry of Science and Technology of the People´s Republic of China
Investigators ^ICMJE
Information Provided By	Peking Union Medical College
Verification Date	March 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP