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

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

This study has been completed.

Sponsors and Collaborators:	Peking Union Medical College Ministry of Science and Technology of the People´s Republic of China
Information provided by:	Peking Union Medical College
ClinicalTrials.gov Identifier:	NCT00618176

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 IV

MedlinePlus related topics:

AIDS

ChemIDplus related topics:

Zidovudine Lamivudine Didanosine Stavudine Nevirapine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment

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
B: Experimental	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
A: Experimental	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
C: Experimental	Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP) Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Responsible Party:	Peking Union Medical College Hospital ( Taisheng Li )
Study ID Numbers:	2004BA719A10, 2004BA719A10
First Received:	February 5, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00618176
Health Authority:	China:Ministry of Science and Technology

Keywords provided by Peking Union Medical College:

Acquired Immunodeficiency Syndrome

adverse effects

Treatment Outcome

Drug Resistance, Viral

treatment naïve

Study placed in the following topic categories:

Virus Diseases

Nevirapine

Sexually Transmitted Diseases, Viral

Stavudine

Didanosine

HIV Infections

Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome

Lamivudine

Zidovudine

Retroviridae Infections

Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

RNA Virus Infections

Anti-HIV Agents

Slow Virus Diseases

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors

Infection

Antiviral Agents

Pharmacologic Actions

Reverse Transcriptase Inhibitors

Anti-Retroviral Agents

Therapeutic Uses

Lentivirus Infections

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 17, 2008