Clinical trial NCT02322827: Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART
Official title: Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Immunodeficiency Syndrome
Human Immunodeficiency Virus Type
Keywords: hiv/aids
Lead sponsor: Triple O Research Institute PA
Sponsor class: OTHER
First posted: 2014-12-23
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are HIV infected and taking antiretroviral therapy

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

Eligibility criteria: 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

Primary outcomes:
measure: Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR
timeFrame: 1 year
Secondary outcomes:
measure: compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR
timeFrame: 2 years
measure: Compare proportion of subjects with viral load less than 50 copies/microL
timeFrame: 1year
measure: Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR
timeFrame: 2 years
measure: Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR
timeFrame: 2 years
measure: Compare the absolute CD4 number increase between a STR and a MTR
timeFrame: 1 year
measure: Compare monthly copay amounts in patients prescribed STR and MTR
timeFrame: 1 year
measure: Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR
timeFrame: 2 years
Other outcomes:
Locations:
city: West Palm Beach
country: United States
facility: Triple O Research Institute PA
state: Florida
Study officials:
affiliation: Triple O Research Institute PA
name: Olayemi Osiyemi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: