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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single tablet regimen | Subjects whose most recent antiretroviral therapy consist of a single tablet regimen | ||
| multiple tablet regimen | Subjects whose most recent antiretroviral therapy consist of multi tablet regimen |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who are HIV infected and taking antiretroviral therapy
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| Name | Affiliation | Role |
|---|---|---|
| Olayemi Osiyemi, M.D. | Triple O Research Institute PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Triple O Research Institute PA | West Palm Beach | Florida | 33401 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| 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 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |