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Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02477527
Recruitment Status : Completed
First Posted : June 22, 2015
Results First Posted : July 2, 2017
Last Update Posted : July 28, 2017
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Midtown Medical Center, Tampa, FL

Brief Summary:
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Condition or disease Intervention/treatment Phase
HIV AIDS Sleep Disorders Drug: Stribild Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
Study Start Date : February 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
Drug Information available for: Atripla

Arm Intervention/treatment
Experimental: Stribild
Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
Drug: Stribild
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.




Primary Outcome Measures :
  1. Percentage of Patients With Viral Loads < 50 Following the Switch [ Time Frame: 24 weeks ]
    percentage of patients with viral loads < 50 following the switch at 24 weeks.


Secondary Outcome Measures :
  1. T-cell Changes [ Time Frame: 24 weeks ]
    Change in CD4 Cell count from baseline to 24 weeks.

  2. Improvements in Central Nervous System Toxicity Score [ Time Frame: 24 weeks ]

    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.


  3. Improvements in Sleep Disorder Score [ Time Frame: 24 weeks ]
    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.


Other Outcome Measures:
  1. Safety as Measured by Side Effects [ Time Frame: 24 weeks ]
    Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477527


Sponsors and Collaborators
Midtown Medical Center, Tampa, FL
Gilead Sciences
Investigators
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Principal Investigator: Edward W Braun, MD Midtown Medical Center

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Responsible Party: Midtown Medical Center, Tampa, FL
ClinicalTrials.gov Identifier: NCT02477527    
Other Study ID Numbers: EB001JP001
First Posted: June 22, 2015    Key Record Dates
Results First Posted: July 2, 2017
Last Update Posted: July 28, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: can be obtained by contacting the investigator only.
Keywords provided by Midtown Medical Center, Tampa, FL:
atripla
stribild
dreams
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents