NCT02477527

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Midtown Medical Center, Tampa, FL · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV
• AIDS
• Sleep Disorders

Interventions

Type	Name	Description
DRUG	Stribild	Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2015-06-22
• Last updated: 2017-07-28
• Results posted: 2017-07-02