NCT02322827

Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 445 (actual)
• Sponsor: Olayemi Osiyemi MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.

Detailed description

This is a phase IV retrospective chart review of HIV infected patients in a private Infectious disease practice in West Palm Beach, FL. This chart review will assign patients into one of two groups based on their antiretroviral regimen: single tablet regimen (STR) versus multi tablet regimen (MTR). Up to 650 patient charts will be reviewed but only about 500 patients are needed for statistical analysis. The primary objective is to look at the proportion of patients with an adherence rate greater than or equal to 95% in subjects prescribed STR versus a MTR. Secondary Objectives: * Differences in emergency room visits, hospitalization and readmission in patients taking a STR vs. a MTR * Proportion of patients with HIV viral load less than 50copies/microliter * Incidence of new onset or worsening hyperlipidemia in patients taking a STR versus a MTR * Incidence of acute renal insufficiency * Compare the absolute CD4 number increase between a STR and a MTR * Compare monthly copay amounts in patients taking a STR versus a MTR * Identify the incidence of opportunistic infections in patients taking a STR versus a MTR

Conditions

• Acquired Immunodeficiency Syndrome
• Human Immunodeficiency Virus Type

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-12-23
• Last updated: 2016-10-28

Locations

1 site across 1 country: United States