A Study of Prevalence of the I50L Mutation When ATV Treated Patients Fail the Regimen

The purpose of this study is to find out the frequency of the I50L substitution among patients experiencing treatment failure on an atazanavir-containing regimen.

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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

Observational

Primary location

Local Institution, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Atazanavir - containing antiretroviral regimen
Confirmed virologic failure defined as either:

HIV RNA by PCR greater than or equal to 1000 copies/mL after achieving a value of <400 copies/mL on at least 2 consecutive measurements or
HIV RNA greater than or equal to 1000 copies/mL after 24 weeks of continuous therapy
At least 18 years old

Exclusion criteria

Unable to give informed consent
Prisoners or subjects involuntarily incarcerated for treatment of psychiatric or physical illness

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase IV, Multicenter, Cross-sectional Study to Evaluate the I50L Substitution Among Subjects Experiencing Virologic Failure on a HAART Regimen Containing Atazanavir (ATV)

Important dates

Study start: 2004
Primary completion: 2009
Study completion: 2009
First posted: Aug 26, 2005
Registry last updated: Apr 14, 2011

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