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Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Primary Purpose

HIV, AIDS, Sleep Disorders

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Stribild
Sponsored by
Midtown Medical Center, Tampa, FL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring atripla, stribild, dreams

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV+ subjects 18 years of age or older
  • estimated Glomerular Filtration Rate > 70 mL/min
  • must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load < 50 copies/mL
  • no antiretrovirals prior to the initiation of Atripla
  • baseline genotyping

Exclusion Criteria:

  • pregnancy
  • unable to provide informed consent
  • enrolled in another study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Stribild

    Arm Description

    Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.

    Outcomes

    Primary Outcome Measures

    Percentage of Patients With Viral Loads < 50 Following the Switch
    percentage of patients with viral loads < 50 following the switch at 24 weeks.

    Secondary Outcome Measures

    T-cell Changes
    Change in CD4 Cell count from baseline to 24 weeks.
    Improvements in Central Nervous System Toxicity Score
    Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale. The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for "None", 1 for "Mild", 2 for "Moderate" and 3 for "Severe". The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures.
    Improvements in Sleep Disorder Score
    Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.

    Full Information

    First Posted
    June 17, 2015
    Last Updated
    June 30, 2017
    Sponsor
    Midtown Medical Center, Tampa, FL
    Collaborators
    Gilead Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02477527
    Brief Title
    Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
    Official Title
    Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Midtown Medical Center, Tampa, FL
    Collaborators
    Gilead Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
    Detailed Description
    Stribild is a preferred regimen in the Department of Health and Human Services guidelines and has demonstrated non-inferiority to Atripla in treatment naïve patients out to 144 weeks (GS-102). Stribild also has statistically significant less Central Nervous System side effects, sleep disturbances and lipid elevations compared to Atripla. This study will evaluate the efficacy, safety, changes in Central Nervous System abnormalities and sleep disorders following a switch from virologically suppressed subjects on Atripla to Stribild.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV, AIDS, Sleep Disorders
    Keywords
    atripla, stribild, dreams

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    21 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Stribild
    Arm Type
    Experimental
    Arm Description
    Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
    Intervention Type
    Drug
    Intervention Name(s)
    Stribild
    Intervention Description
    Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
    Primary Outcome Measure Information:
    Title
    Percentage of Patients With Viral Loads < 50 Following the Switch
    Description
    percentage of patients with viral loads < 50 following the switch at 24 weeks.
    Time Frame
    24 weeks
    Secondary Outcome Measure Information:
    Title
    T-cell Changes
    Description
    Change in CD4 Cell count from baseline to 24 weeks.
    Time Frame
    24 weeks
    Title
    Improvements in Central Nervous System Toxicity Score
    Description
    Changes in Central Nervous System toxicity score at week 24 as measured by SSAT 047 scale. The scale is a questionnaire that participants complete at each visit. The SSAT 047 scores 10 items related to efavirenz side effects including: dizziness, depression, insomnia, anxiety, confusion, impaired concentration, headache, somnolence, aggressive mood and abnormal dreams. The side effects were scored as 0 for "None", 1 for "Mild", 2 for "Moderate" and 3 for "Severe". The scores for the 10 items ranged from 0(none) - 3(severe), and the total score is 0-30. The scores are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures.
    Time Frame
    24 weeks
    Title
    Improvements in Sleep Disorder Score
    Description
    Changes in quality of sleep at week 24 as measured by Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) is used to measure the quality and patterns of sleep in adults. It rates sleep based on seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. It is a self-administered questionnaire covering these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. The scores for the 7 items ranged from 0(none) - 3(severe), and the total score is 0-21. The reported values in the table represent the change in the overall scores on the PSQI scale. The values were added and reported as the sum of the individual measures. A negative score correlates with improvement of the sleep quality.
    Time Frame
    24 weeks
    Other Pre-specified Outcome Measures:
    Title
    Safety as Measured by Side Effects
    Description
    Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.
    Time Frame
    24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV+ subjects 18 years of age or older estimated Glomerular Filtration Rate > 70 mL/min must currently be on Atripla and taking it for at least 3 months with a HIV-1 Viral Load < 50 copies/mL no antiretrovirals prior to the initiation of Atripla baseline genotyping Exclusion Criteria: pregnancy unable to provide informed consent enrolled in another study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Edward W Braun, MD
    Organizational Affiliation
    Midtown Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    can be obtained by contacting the investigator only.

    Learn more about this trial

    Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

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