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

Phase 4

Completed

• Conditions: HIV Infections
• Interventions: Drug: Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP); Drug: Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP); Drug: Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)

• Registration Number: NCT00618176
• Lead Sponsor: Peking Union Medical College

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-09
• Study First Submitted: 2008-02-05
• Study First Submitted QC: 2008-02-15
• Study First Posted: 2008-02-18
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-21
• Last Update Posted: 2008-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Stavudine (d4T), Lamivudine (3TC), Nevirapine (NVP)	-
A	Zidovudine (AZT)+ Didanosine (ddI)+ Nevirapine (NVP)	-
C	Zidovudine (AZT), Lamivudine (3TC), Nevirapine (NVP)	-

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China