Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-01-31

Brief Summary

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

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Detailed Description

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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

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HIV AIDS Sleep Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stribild

Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.

Group Type EXPERIMENTAL

Stribild

Intervention Type DRUG

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

Interventions

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Stribild

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

Intervention Type DRUG

Eligibility Criteria

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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