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OpenTrials
Completed

NCT Number: NCT01450618

Comparative Tolerability of Protease Inhibitors

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.

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Key information

Conditions

HIV

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percent of patients.with new onset GI symptoms after initiating an ATV, DRV, FPV, or LPV containing combination antiretroviral therapy (cART) regimen

    Time frame: 6 months

Secondary outcomes

  1. 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

    Time frame: 6 months

  2. Healthcare utilization

    Time frame: 6 months

  3. Healthcare costs

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Comparative Tolerability of Protease Inhibitors and the Associated Impact on Persistence, Healthcare Utilization, and Healthcare Costs

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 12, 2011
Registry last updated
Dec 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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