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

Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.

Study Overview

• Status: Completed
• Conditions: HIV; Sleep Disorders; AIDS
• Intervention / Treatment: Drug: Stribild

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stribild; Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.	Drug: Stribild; Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Viral Loads < 50 Following the Switch	percentage of patients with viral loads < 50 following the switch at 24 weeks.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
T-cell Changes	Change in CD4 Cell count from baseline to 24 weeks.	24 weeks
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.	24 weeks
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.	24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as Measured by Side Effects	Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.	24 weeks

Collaborators and Investigators

• Sponsor: Midtown Medical Center, Tampa, FL
• Collaborators: Gilead Sciences
• Investigators: Principal Investigator: Edward W Braun, MD, Midtown Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: June 17, 2015
• First Submitted That Met QC Criteria: June 19, 2015
• First Posted (Estimate): June 22, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: June 30, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: atripla; stribild; dreams
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders; Dyssomnias; Parasomnias; Anti-Infective Agents; Antiviral Agents; Anti-HIV Agents; Anti-Retroviral Agents; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
• Other Study ID Numbers: EB001JP001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: can be obtained by contacting the investigator only.