Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | November 2014 |
| End Date: | August 2015 |
| Contact: | Olayemi Osiyemi, MD |
| Email: | drtripleo@tripleoresearch.com |
| Phone: | 561-855-7871 |
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.
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
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
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
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