HIV
Conditions
Brief summary
This study will be a retrospective observational study assessing identifiable tolerability problems in terms of their comparative incidence among Human Immunodeficiency Virus (HIV) patients treated with cART regimens including one of four different protease inhibitors \[Atazanavir sulfate (ATV), Darunavir (DRV), Fosamprenavir (FPV), or Lopinavir (LPV)\] and the impact of these identifiable tolerability problems on PI persistence, healthcare utilization, and healthcare costs.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Initiated treatment with a Protease inhibitor (PI)-based Combination antiretroviral therapy (cART) regimen * Between 18-64 years of age on the index date * At least 6 months of continuous enrollment and pharmacy benefits prior to the index date * At least 6 months of continuous enrollment and pharmacy benefits following the index date * At least 1 medical claim during the 6-month follow-up period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients with new onset lipid abnormalities or new onset jaundice (separately) after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen | 6 months |
| Healthcare utilization | 6 months |
| Healthcare costs | 6 months |
Outcome results
None listed