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

Sponsor
Olayemi Osiyemi MD (Other)
Overall Status
Completed
CT.gov ID
NCT02322827
Collaborator
(none)
445
Enrollment
1
Location
23
Duration (Months)
19.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    445 participants
    Time Perspective:
    Retrospective
    Official Title:
    Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
    Study Start Date :
    Nov 1, 2014
    Actual Primary Completion Date :
    Oct 1, 2016
    Actual Study Completion Date :
    Oct 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR [2 years]

      composite

    2. Compare proportion of subjects with viral load less than 50 copies/microL [1year]

    3. Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR [2 years]

    4. Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR [2 years]

    5. Compare the absolute CD4 number increase between a STR and a MTR [1 year]

    6. Compare monthly copay amounts in patients prescribed STR and MTR [1 year]

    7. Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Triple O Research Institute PA West Palm Beach Florida United States 33401

    Sponsors and Collaborators

    • Olayemi Osiyemi MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Olayemi Osiyemi MD, President, Triple O Research Institute PA
    ClinicalTrials.gov Identifier:
    NCT02322827
    Other Study ID Numbers:
    • IN-US-236-1642
    First Posted:
    Dec 23, 2014
    Last Update Posted:
    Oct 28, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Olayemi Osiyemi MD, President, Triple O Research Institute PA
    hiv/aids
    Additional relevant MeSH terms:
    Acquired Immunodeficiency Syndrome
    HIV Infections
    Immunologic Deficiency Syndromes

    Study Results

    No Results Posted as of Oct 28, 2016