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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00618176
First Posted: February 18, 2008
Last Update Posted: March 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by:
Peking Union Medical College
  Purpose
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 .

Condition Intervention Phase
HIV Infections Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP) Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP) Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Enrollment: 198
Study Start Date: January 2005
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: B 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
Experimental: A 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
Experimental: C Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)
Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00618176


Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Peking Union Medical College
Ministry of Science and Technology of the People´s Republic of China
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Taisheng Li, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT00618176     History of Changes
Other Study ID Numbers: 2004BA719A10
First Submitted: February 5, 2008
First Posted: February 18, 2008
Last Update Posted: March 24, 2008
Last Verified: March 2008

Keywords provided by Peking Union Medical College:
Acquired Immunodeficiency Syndrome
adverse effects
Treatment Outcome
Drug Resistance, Viral
treatment naïve

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine
Zidovudine
Nevirapine
Stavudine
Didanosine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Antimetabolites
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers