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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; Human Immunodeficiency Virus Type

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 Type: Observational
• Enrollment (Actual): 445

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • Triple O Research Institute PA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are HIV infected and taking antiretroviral therapy

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Olayemi Osiyemi MD
• Investigators: Principal Investigator: Olayemi Osiyemi, M.D., Triple O Research Institute PA

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: hiv/aids
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: IN-US-236-1642

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided