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

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 .

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Key information

Conditions

HIV Infections Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

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

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

Drug

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

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

Drug

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College

Other

Collaborators

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

Registry information

Important dates

Study start: 2005
Primary completion: 2006
First posted: Feb 18, 2008
Registry last updated: Mar 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed