Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

Completed

• Conditions: Human Immunodeficiency Virus Type; Acquired Immunodeficiency Syndrome

• Registration Number: NCT02322827
• Lead Sponsor: Olayemi Osiyemi MD

Brief 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.

Detailed 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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-12-17
• Study First Posted: 2014-12-23
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 445

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR	2 years
Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR	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
Compare monthly copay amounts in patients prescribed STR and MTR	1 year
compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR	2 years	composite
Compare the absolute CD4 number increase between a STR and a MTR	1 year

Trial Locations

Locations (1)

Triple O Research Institute PA; 🇺🇸 West Palm Beach, Florida, United States