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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

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

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

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

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Acquired Immunodeficiency Syndrome, adverse effects, Treatment Outcome, Drug Resistance, Viral, treatment naïve

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00618176

First Posted

February 5, 2008

Last Updated

March 21, 2008

Sponsor

Peking Union Medical College

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00618176

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2008

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Peking Union Medical College

Collaborators

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

4. Oversight

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

198 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Intervention Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

19081791

Citation

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.

Results Reference

derived

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

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