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Clinical Trial 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.


Clinical Trial 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 ;


Study Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


NCT number NCT02322827
Study type Observational
Source Triple O Research Institute PA
Contact
Status Completed
Phase N/A
Start date November 2014
Completion date October 2016

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