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

NCT ID: NCT00618176

Last Updated: 2008-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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 .

Detailed Description

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Conditions

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HIV Infections

Keywords

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Acquired Immunodeficiency Syndrome adverse effects Treatment Outcome Drug Resistance, Viral treatment naïve

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B

Group Type EXPERIMENTAL

Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)

Intervention Type DRUG

Stavudine (d4T) 30mg bid (W\>60Kg)20mg bid (W\<60Kg) Lamivudine (3TC)300mg qd Nevirapine (NVP)200mg bid

A

Group Type EXPERIMENTAL

Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)

Intervention Type DRUG

Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W\>60Kg)125mg bid (W\<60Kg) Nevirapine (NVP) 200mg bid

C

Group Type EXPERIMENTAL

Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)

Intervention Type DRUG

Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid

Interventions

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Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)

Zidovudine (AZT) 300mg bid Didanosine (ddI) 200mg bid (W\>60Kg)125mg bid (W\<60Kg) Nevirapine (NVP) 200mg bid

Intervention Type 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

Intervention Type DRUG

Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)

Zidovudine (AZT) 300mg bid Lamivudine (3TC) 300mg qd Nevirapine (NVP) 200mg bid

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology of the People´s Republic of China

OTHER_GOV

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, , China

Site Status

Countries

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China

References

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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. doi: 10.1371/journal.pone.0003918. Epub 2008 Dec 12.

Reference Type DERIVED
PMID: 19081791 (View on PubMed)

Other Identifiers

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2004BA719A10

Identifier Type: -

Identifier Source: secondary_id

2004BA719A10

Identifier Type: -

Identifier Source: org_study_id