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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT00135447

AI424-128

Details and patient eligibility

About

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

5,000 participants in 1 patient group

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