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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT00618176
First received: February 5, 2008
Last updated: March 21, 2008
Last verified: March 2008

February 5, 2008
March 21, 2008
January 2005
September 2006   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00618176 on ClinicalTrials.gov Archive Site
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Three Generic Nevirapine-Based Antiretroviral Treatments in Chinese Patients:Multicentric Observation Cohort
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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 .

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)
    Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W>60Kg)125mg bid (W<60Kg) Nevirapine (NVP) 200mg bid
  • Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)
    Stavudine (d4T) 30mg bid (W>60Kg)20mg bid (W<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid
  • Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
    Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid
  • Experimental: B
    Intervention: Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)
  • Experimental: A
    Intervention: Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)
  • Experimental: C
    Intervention: Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
198
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September 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00618176
2004BA719A10, 2004BA719A10
Not Provided
Taisheng Li, Peking Union Medical College Hospital
Peking Union Medical College
Ministry of Science and Technology of the People´s Republic of China
Not Provided
Peking Union Medical College
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP