Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Information source: Midtown Medical Center, Tampa, FL
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV; AIDS; Sleep Disorders
Intervention: elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Midtown Medical Center, Tampa, FL Official(s) and/or principal investigator(s): Edward W Braun, MD, Principal Investigator, Affiliation: Midtown Medical Center
Summary
Switch patients from Atripla to Stribild will be evaluated to see if patients have less
sleep disturbances.
Clinical Details
Official title: Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: percentage of patients with viral loads < 50 following the switch
Secondary outcome: T-cell changesimprovements in Central Nervous System toxicity score improvements in sleep disorder score
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2015
Last updated: June 19, 2015
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