Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acquired Immunodeficiency Syndrome, Human Immunodeficiency Virus Type

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female (gender at birth), age 18 years or older Documented HIV-1 infection by western blot or HIV viral load Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months Patients should have a minimum of 3 office visits Exclusion Criteria: Patients who were evaluated in the hospital but never came to the clinic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single tablet regimen<br>Subjects whose most recent antiretroviral therapy consist of a single tablet regimen | |
| multiple tablet regimen<br>Subjects whose most recent antiretroviral therapy consist of multi tablet regimen | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR | composite | 2 years | 
| Compare proportion of subjects with viral load less than 50 copies/microL |  | 1year | 
| Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR |  | 2 years | 
| Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR |  | 2 years | 
| Compare the absolute CD4 number increase between a STR and a MTR |  | 1 year | 
| Compare monthly copay amounts in patients prescribed STR and MTR |  | 1 year | 
| Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hiv/aids