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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00618176

Enrollment

198

Registered

2008-02-18

Start date

2005-01-31

Completion date

Unknown

Last updated

2008-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

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

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 .

Interventions

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

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

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026