Atripla to Stribild Switch Study to Evaluate Sleep Disturbances

Midtown Medical Center, Tampa, FL

Status and phase: Completed; Phase 4

Conditions: Sleep Disorders; AIDS; HIV

Treatments: Drug: Stribild

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02477527

EB001JP001

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Stribild

Experimental group

Description:

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

Treatment:

Drug: Stribild