Durability of Nevirapine-Based Antiretroviral Regimen

Although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including Thailand due to its accessibility and affordability. In addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.To date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.

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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

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Medicine, Bamrasnaradura Infectious Diseases Institute

Nonthaburi, Changwat Nonthaburi, 11000, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

HIV-infected individuals ≥15 years of age
CD4 cell count <350 cells/mm3
Willing to participate and give consent form

Exclusion criteria

previous antiretroviral therapy
pregnancy
receiving a medication that has drug-drug interactions with NVP or RFP
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >5 times of upper limit of normal range

Treatment and study plan

Nevirapine

Drug

200 mg/day twice a day

Other names: GPO-vir

Primary outcomes

number of patients with undetectable plasma HIV-1 viral load

Time frame: 240 weeks

Sponsors and collaborators

Lead sponsor

Bamrasnaradura Infectious Diseases Institute

Other Gov

Registry information

Official study title

Durability of Stavudine, Lamivudine and Nevirapine Among Advanced HIV-1 Infected Patients With/Without Prior Co-Administration of Rifampicin: A 144-Week Prospective Study

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2010
First posted: Jun 24, 2008
Registry last updated: Jul 8, 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.

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