Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
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|ClinicalTrials.gov Identifier: NCT02477527|
Recruitment Status : Completed
First Posted : June 22, 2015
Results First Posted : July 2, 2017
Last Update Posted : July 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV AIDS Sleep Disorders||Drug: Stribild||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
- 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.
- T-cell Changes [ Time Frame: 24 weeks ]Change in CD4 Cell count from baseline to 24 weeks.
- 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.
- 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.
- 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.
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
|Principal Investigator:||Edward W Braun, MD||Midtown Medical Center|