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Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Triple O Research Institute PA
West Palm Beach, Florida, United States
Start Date
November 1, 2014
Primary Completion Date
October 1, 2016
Completion Date
October 1, 2016
Last Updated
October 28, 2016
445
ACTUAL participants
Lead Sponsor
Olayemi Osiyemi MD
NCT02494986
NCT06891066
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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