HIVPhase 4NCT02477527
Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
A Phase 4 study testing Stribild in people with HIV and AIDS, run by Midtown Medical Center, Tampa, FL.
Trial summary
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, AIDS, Sleep Disorders
- What is being tested?
- Stribild
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- unable to provide informed consent
- enrolled in another study
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV, AIDS, Sleep Disorders
- Being tested
- Stribild
- Keywords
- atripla, stribild, dreams
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StribildDrug
Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
| Study group | Role | What they receive |
|---|---|---|
| Stribild | Experimental | Patients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. Receives: Drug: Stribild |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Viral Loads < 50 Following the Switch
percentage of patients with viral loads < 50 following the switch at 24 weeks.
Measured: 24 weeks
Secondary outcomes (3)
T-cell Changes
Change in CD4 Cell count from baseline to 24 weeks.
Measured: 24 weeks
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 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.
Measured: 24 weeks
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 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.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midtown Medical Center, Tampa, FL
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Edward W Braun, MD, Principal investigator, Midtown Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477527
- Sponsor's protocol ID
- EB001JP001
- Status last verified
- Jun 2017
- First submitted
- 17 Jun 2015
- Last updated
- 28 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: can be obtained by contacting the investigator only.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switching From Atripla to Stribild Leads to Improvements in Central Nervous System Side Effects and Sleep Disturbances
- ClinicalTrials.gov ID
- NCT02477527
- Acronym / sponsor ID
- EB001JP001
- Conditions
- HIV, AIDS, Sleep Disorders
- Keywords
- atripla, stribild, dreams
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Midtown Medical Center, Tampa, FLUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jun 2015 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Switch patients from Atripla to Stribild will be evaluated to see if patients have less sleep disturbances.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stribild | Experimental | Drug: StribildPatients to be changed from Atripla to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil and observed for changes in sleep patterns / sleep disturbances. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- pregnancy
- unable to provide informed consent
- enrolled in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StribildChange subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day. | Drug | Stribild |
Primary outcome
Percentage of Patients With Viral Loads < 50 Following the Switch
Time frame: 24 weeks
percentage of patients with viral loads < 50 following the switch at 24 weeks.
3 secondary outcomes
T-cell Changes
Time frame: 24 weeks
Improvements in Central Nervous System Toxicity Score
Time frame: 24 weeks
Improvements in Sleep Disorder Score
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. can be obtained by contacting the investigator only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward W Braun, MD principal investigator
Midtown Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stribild in people with HIV and AIDS, run by Midtown Medical Center, Tampa, FL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Viral Loads < 50 Following the Switch (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.