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NCT00618176 Clinical Trial

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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00618176
Other study ID # 2004BA719A10
Secondary ID 2004BA719A10
Status Completed
Phase Phase 4
First received February 5, 2008
Last updated March 21, 2008
Start date January 2005

Study information
Verified date March 2008
Source Peking Union Medical College
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical Trial 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 .

Recruitment information / eligibility
Status Completed
Enrollment 198
Est. completion date
Est. primary completion date September 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing

Sponsors (2)
Lead Sponsor Collaborator
Peking Union Medical College Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

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