Trial Outcomes & Findings for Atripla to Stribild Switch Study to Evaluate Sleep Disturbances (NCT NCT02477527)

NCT ID: NCT02477527

Last Updated: 2017-07-28

Results Overview

percentage of patients with viral loads \< 50 following the switch at 24 weeks.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2017-07-28

Participant Flow

Recruited from private office practice.

Participants had to be stable on Atripla for at least 6 months with undetectable viral load.

Participant milestones

Measure	Study Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Overall Study STARTED	27
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Study Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1
Overall Study Screen Failure	3

Baseline Characteristics

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Baseline characteristics by cohort

Measure	Stribild n=27 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Age, Continuous	48.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: Participants completing the study.

percentage of patients with viral loads < 50 following the switch at 24 weeks.

Outcome measures

Measure	Study n=21 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: 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	20 Participants

SECONDARY outcome

Timeframe: 24 weeks

Population: Participants completing the study.

Change in CD4 Cell count from baseline to 24 weeks.

Outcome measures

Measure	Study n=21 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
T-cell Changes	151 cells / cc Interval 5.0 to 644.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Study n=21 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Improvements in Central Nervous System Toxicity Score	2.0 units on a scale Interval -1.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Study n=21 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Improvements in Sleep Disorder Score	-4 units on a scale Interval -17.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks

Population: no adverse effects reported.

Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.

Outcome measures

Measure	Study n=21 Participants Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil: Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Safety as Measured by Side Effects	0 Participants

Adverse Events

Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Edward W Braun, MD

Midtown Medical Center

Phone: 8139353221

Email: Dr.Braun@DrEdwardBraun.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place