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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00135447

Enrollment

5000

Registered

2005-08-26

Start date

2004-09-30

Completion date

2009-09-30

Last updated

2011-04-14

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

Conditions

HIV Infections

Keywords

HIV/AIDS, Treatment Experienced

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Atazanavir - containing antiretroviral regimen * Confirmed virologic failure defined as either: 1. 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 2. 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

Countries

United States

Outcome results