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

Peking Union Medical College

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

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

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

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00618176

2004BA719A10

Details and patient eligibility

About

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 .

Enrollment

198 patients

Sex

All

Ages

18+ years old

Volunteers

No 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