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

This study has been completed.

First Received: February 5, 2008 Last Updated: March 21, 2008 History of Changes

Sponsor:	Peking Union Medical College
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine Didanosine Nevirapine Lamivudine Stavudine

U.S. FDA Resources

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

No publications provided by Peking Union Medical College

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Peking Union Medical College Hospital ( Taisheng Li )
Study ID Numbers:	2004BA719A10, 2004BA719A10
Study First Received:	February 5, 2008
Last Updated:	March 21, 2008
ClinicalTrials.gov Identifier:	NCT00618176 History of Changes
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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Stavudine
Molecular Mechanisms of Pharmacological Action
Zidovudine
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Nevirapine
Didanosine
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on November 30, 2009