Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

HIV Clinical Trial

Official title:

Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477527
• Other study ID #: EB001JP001
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2015
• Last updated: June 26, 2017
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2017
• Source: Midtown Medical Center, Tampa, FL
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AIDS
• Dyssomnias
• HIV
• Parasomnias
• Sleep Disorders
• Sleep Wake Disorders

Intervention

Drug:
• Stribild
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Midtown Medical Center, Tampa, FL	Gilead Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety as Measured by Side Effects	Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.	24 weeks
Primary	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	T-cell Changes	Change in CD4 Cell count from baseline to 24 weeks.	24 weeks
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 are then averaged to determine the overall impact on central nervous system symptoms and reported as the sum of the measures.	24 weeks
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 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