Subjects experiencing virologic failure after a HAART regimen containing ATV
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject must be able to understand the informed consent and to provide written informed consent; - Subjects currently on an antiretroviral regimen containing ATV with either: 1) a confirmed virologic rebound (an HIV RNA = 1000 copies/mL, after achieving a value =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - VL <1000 c/mL at the screening visit. - Individuals exhibiting virologic failure on a HAART regimen that does not include ATV. - Subjects who are incapable to give informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the prevalence of the I50L substitution in viral isolates from subjects virologically failing ATV-containing HAART regimens with the I50L substitution prevalence in subjects failing ATV/r-containing HAART regimens, regardless of prior treatment history.;Secondary Objective: - To determine the overall prevalence of the I50L substitution in subjects failing ATV-containing HAART regimens. - To compare the prevalence of the I50L substitution in subjects failing ATV/r as a first PI-containing regimen versus subjects failing ATV/r as a second or later PI-containing regimen. - To compare the prevalence of the I50L substitution in subjects failing ATV as a first PI-containing regimen versus subjects failing ATV as a second or later PI-containing regimen. - To compare the prevalence of the I50L substitution (regardless of ritonavir combination) in subjects failing ATV as a first PI-containing regimen versus subjects failing ATV as a second or later PI-containing regimen. - To describe patterns of amino acid substitutions in subjects failing on ATV compared with ATV/r. - To determine if the I50L substitution is associated with: 1) other specific protease substitutions, 2) NRTI substitutions.;Primary end point(s): The prevalence of the I50L substitution in viral isolates from subjects virologically failing ATV-containing HAART regimens with the I50L substitution prevalence in subjects failing ATV/r-containing HAART regimens, regardless of prior treatment history. | — |
Countries
Germany, Italy, United Kingdom
Outcome results
None listed