Title
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
Phase
Phase 4Lead Sponsor
Midtown Medical Center, Tampa, FLStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HIV AIDS Sleep DisordersIntervention/Treatment
tenofovir emtricitabine cobicistat elvitegravir ...Study Participants
21Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
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.
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
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
| Event Type | Organ System | Event Term |
|---|
percentage of patients with viral loads < 50 following the switch at 24 weeks.
Change in CD4 Cell count from baseline to 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.
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.
Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.
