Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

Acquired Immunodeficiency Syndrome Clinical Trial

— HOST  

Official title:

Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322827
• Other study ID #: IN-US-236-1642
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: October 26, 2016
• Start date: November 2014
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Triple O Research Institute PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Type
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
United States	Triple O Research Institute PA	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Olayemi Osiyemi MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR	composite	2 years	Yes
Secondary	Compare proportion of subjects with viral load less than 50 copies/microL		1year	No
Secondary	Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR		2 years	Yes
Secondary	Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR		2 years	Yes
Secondary	Compare the absolute CD4 number increase between a STR and a MTR		1 year	Yes
Secondary	Compare monthly copay amounts in patients prescribed STR and MTR		1 year	No
Secondary	Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR		2 years	Yes