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Completed

NCT Number: NCT02322827

Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR

    Time frame: 1 year

Secondary outcomes

  1. compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR

    Time frame: 2 years

    composite

  2. Compare proportion of subjects with viral load less than 50 copies/microL

    Time frame: 1year

  3. Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR

    Time frame: 2 years

  4. Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR

    Time frame: 2 years

  5. Compare the absolute CD4 number increase between a STR and a MTR

    Time frame: 1 year

  6. Compare monthly copay amounts in patients prescribed STR and MTR

    Time frame: 1 year

  7. Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Olayemi Osiyemi MD

Other

Registry information

Official study title

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

Acronym: HOST

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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