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