HIV, AIDS, Sleep Disorders
Conditions
Keywords
atripla, stribild, dreams
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.
Interventions
DRUGStribild
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Sponsors
Gilead Sciences
Midtown Medical Center, Tampa, FL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Viral Loads < 50 Following the Switch | 24 weeks | percentage of patients with viral loads \< 50 following the switch at 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T-cell Changes | 24 weeks | Change in CD4 Cell count from baseline to 24 weeks. |
| Improvements in Central Nervous System Toxicity Score | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety as Measured by Side Effects | 24 weeks | Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires. |
Participant flow
Recruitment details
Recruited from private office practice.
Pre-assignment details
Participants had to be stable on Atripla for at least 6 months with undetectable viral load.
Participants by arm
| Arm | Count |
|---|---|
| Stribild 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. | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Screen Failure | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Stribild |
|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
Percentage of Patients With Viral Loads < 50 Following the Switch
percentage of patients with viral loads \< 50 following the switch at 24 weeks.
Time frame: 24 weeks
Population: Participants completing the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Percentage of Patients With Viral Loads < 50 Following the Switch | 20 Participants |
Secondary
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study | Improvements in Central Nervous System Toxicity Score | 2.0 units on a scale |
Secondary
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.
Time frame: 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study | Improvements in Sleep Disorder Score | -4 units on a scale |
Secondary
T-cell Changes
Change in CD4 Cell count from baseline to 24 weeks.
Time frame: 24 weeks
Population: Participants completing the study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study | T-cell Changes | 151 cells / cc |
Other Pre-specified
Safety as Measured by Side Effects
Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.
Time frame: 24 weeks
Population: no adverse effects reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study | Safety as Measured by Side Effects | 0 Participants |