Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART (HOST)

Olayemi Osiyemi MD

Status: Completed

Conditions: Human Immunodeficiency Virus Type; Acquired Immunodeficiency Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02322827

IN-US-236-1642

Details and patient eligibility

About

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.

Full 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

Enrollment: 445 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

445 participants in 2 patient groups

single tablet regimen

Description:

Subjects whose most recent antiretroviral therapy consist of a single tablet regimen

multiple tablet regimen

Description:

Subjects whose most recent antiretroviral therapy consist of multi tablet regimen