Comparative Tolerability of Protease Inhibitors

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: HIV

Study type: Observational

Funder types: Industry

Identifiers

NCT01450618

AI424-435

Details and patient eligibility

About

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.

Enrollment: 26,000 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

26,000 participants in 4 patient groups

Atazanavir

Description:

HIV patients on antiretroviral therapy using Atazanavir

Darunavir

Description:

HIV patients on antiretroviral therapy using Darunavir

Fosamprenavir

Description:

HIV patients on antiretroviral therapy using Fosamprenavir

Lopinavir

Description:

HIV patients on antiretroviral therapy using Lopinavir