Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
30. juni 2017 opdateret af: Midtown Medical Center, Tampa, FL
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.
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
Fase
- Fase 4
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Stribild
Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances.
|
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Patients With Viral Loads < 50 Following the Switch
Tidsramme: 24 weeks
|
percentage of patients with viral loads < 50 following the switch at 24 weeks.
|
24 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
T-cell Changes
Tidsramme: 24 weeks
|
Change in CD4 Cell count from baseline to 24 weeks.
|
24 weeks
|
|
Improvements in Central Nervous System Toxicity Score
Tidsramme: 24 weeks
|
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
Tidsramme: 24 weeks
|
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
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety as Measured by Side Effects
Tidsramme: 24 weeks
|
Monitor for any side effects that are spontaneously reported by subjects and reported on questionnaires.
|
24 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Edward W Braun, MD, Midtown Medical Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. februar 2015
Primær færdiggørelse (Faktiske)
1. december 2015
Studieafslutning (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først indsendt
17. juni 2015
Først indsendt, der opfyldte QC-kriterier
19. juni 2015
Først opslået (Skøn)
22. juni 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EB001JP001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
can be obtained by contacting the investigator only.
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