HIVPhase 4DeepSwitchNCT02447016
Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera
A Phase 4 study testing Tenofovir disoproxil/emtricitabine/rilpivirine and Tenofovir disoproxil/emtricitabine/efavirenz in people with HIV, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The aim of this prospective, open label study is to check for differences in neuropsychiatric and neurocognitive measurements among patients that will be switched from Atripla to Eviplera among 40 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Tenofovir disoproxil/emtricitabine/rilpivirine and Tenofovir disoproxil/emtricitabine/efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to 21 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Ability to understand and sign a written informed consent form
- Receiving Atripla continuously for >12 weeks preceding the screening visit
- Plasma HIV-1 RNA levels (at least in two measurements) <50 copies/mL for >8 weeks prior to the screening visit and at the screening visit
- Atripla or Truvada + Efavirenz was the first antiretroviral regimen and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA <50 copies/mL
- Had a genotype prior to starting study drugs and no known resistance to any of the study drugs
- Normal ECG
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- Hepatic transaminase (AST and ALT) <5 X upper limit of normal (ULN)
- Total bilirubin <1.5 mg/dL
- eGFR > 60 mL/min
- Neutrophil count > 1000/mm3, platelets >50,000/mm3. Haemoglobin > 8.5 g/dL
- Age > 18
- Males and Females of childbearing potential must have agreed to utilize highly effective contraception methods (two separate forms of contraception, one of which must be an effective barrier method, or be nonheterosexually active, practice sexual abstinence, or have a vasectomized partner) from screening throughout the duration of the study period and for 60 days following the last dose of study drug.
Who cannot join
- Subjects with known allergy to one of the study drugs
- AIDS defining event diagnosed within 21 days prior to screening
- Females who are pregnant or breast feeding
- Acute hepatitis diagnosed within 21 days prior to screening
- Subjects receiving drug treatment for HCV or subjects anticipated to receive treatment for HCV during the course of the study
- Implanted defibrillator or pacemaker
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- Current alcohol or drug abuse judged by the investigator to potentially interfere with subject adherence
- Participation in another interventional trial
- Ongoing therapy or anticipated need to initiate drugs during the study that are contraindicated or not recommended for use with study drugs (Carbamazepine, Dexamethasone, Esomeprazole, Fosphenytoin, Lansoprazole, Omeprazole, Oxcarbazepine, Pantoprazole, Phenobarbital, Phenytoin, Piperaquine, Primnidone, Rabeprazole, Rifabutin, Rifampin, Rifapentine, St John's Wort
- Any Severe Psychiatric disease that judged by the investigator to potentially interfere with subject adherence to protocol or to drugs or that may interfere with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
The aim of this prospective, open label study is to check for differences in neuropsychiatric and neurocognitive measurements among patients that will be switched from Atripla to Eviplera among 40 patients.
Read the detailed description
40 patients on Atripla for at least 12 weeks with undetectable HIV-1 viral load will be randomly assigned to one of two groups in a ratio of 1:1: half of the patients will be switched to Eviplera and half will remain on Atripla. Neuropsychiatric symptoms will be evaluated using specific questionnaires (anxiety and depression scales, sleeping quality scale, etc) and neurocognitive functions will be assessed using standard tests (Trail A and B, memory tests, etc). Patient satisfaction will be assessed using a visual analog scale. Treatment efficacy will be evaluated by measuring the rate of patients with HIV vilral load under 50 copies/mL.
- Conditions
- HIV
- Being tested
- Tenofovir disoproxil/emtricitabine/rilpivirine, Tenofovir disoproxil/emtricitabine/efavirenz
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir disoproxil/emtricitabine/rilpivirineDrug
Also called eviplera, complera
Tenofovir disoproxil/emtricitabine/efavirenzDrug
Also called Atripla
| Study group | Role | What they receive |
|---|---|---|
| eviplera (complera) | Experimental | Tab eviplera QD Receives: Drug: Tenofovir disoproxil/emtricitabine/rilpivirine |
| atripla | Active comparator | Tab Atripla QD Receives: Drug: Tenofovir disoproxil/emtricitabine/efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
depression (questionaire)
PHQ which is a validated questionaire for depression
Measured: 12 month
anxiety (questionaire)
STAI which is a validated questionaire for anxiety
Measured: 12 month
sleeping quality (questionaire)
a validated questionaire
Measured: 12 month
Secondary outcomes (7)
Hopkins Verbal Learning Test - Revised (test result in numbers)
a validated test for memory testing
Measured: 12 month
Satisfaction (scale)
Visual Analogue Scale (VAS)
Measured: 12 month
viral load (copies/mL)
efficacy of treatment in keeping undetectable viral load
Measured: 24 month
color trail test - 2 parts (test result in numbers)
a line drawing test which connects points in a certain order. It serves as a general neurocognitive function test
Measured: 12 month
grooved pegboard test (test result in numbers)
a specific test which serves as a general neurocognitive function test and was validated in HIV patients
Measured: 12 month
clock drawing test (test result in numbers)
a general test for dementia
Measured: 12 month
CD4 cell count (number of cells per mm3)
efficacy of treatment in keeping CD4 count from falling after intervention
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startMay 2015
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
Why it stopped: no more participants taking atripla
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Itsik Levi Dr, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447016
- Sponsor's protocol ID
- SHEBA-14-1462-IL-SMC
- Acronym
- DeepSwitch
- Status last verified
- Apr 2017
- First submitted
- 10 May 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
- ClinicalTrials.gov ID
- NCT02447016
- Acronym / sponsor ID
- DeepSwitch / SHEBA-14-1462-IL-SMC
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more participants taking atripla
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2015
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this prospective, open label study is to check for differences in neuropsychiatric and neurocognitive measurements among patients that will be switched from Atripla to Eviplera among 40 patients.
Detailed description
40 patients on Atripla for at least 12 weeks with undetectable HIV-1 viral load will be randomly assigned to one of two groups in a ratio of 1:1: half of the patients will be switched to Eviplera and half will remain on Atripla. Neuropsychiatric symptoms will be evaluated using specific questionnaires (anxiety and depression scales, sleeping quality scale, etc) and neurocognitive functions will be assessed using standard tests (Trail A and B, memory tests, etc). Patient satisfaction will be assessed using a visual analog scale. Treatment efficacy will be evaluated by measuring the rate of patients with HIV vilral load under 50 copies/mL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eviplera (complera) | Experimental | Drug: Tenofovir disoproxil/emtricitabine/rilpivirineTab eviplera QD |
| atripla | Active comparator | Drug: Tenofovir disoproxil/emtricitabine/efavirenzTab Atripla QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ability to understand and sign a written informed consent form
- Receiving Atripla continuously for >12 weeks preceding the screening visit
- Plasma HIV-1 RNA levels (at least in two measurements) <50 copies/mL for >8 weeks prior to the screening visit and at the screening visit
- Atripla or Truvada + Efavirenz was the first antiretroviral regimen and no HIV-1 RNA > 50 copies/mL measured at two consecutive time points after first achieving HIV RNA <50 copies/mL
- Had a genotype prior to starting study drugs and no known resistance to any of the study drugs
Key exclusion criteria (10 listed)
- Subjects with known allergy to one of the study drugs
- AIDS defining event diagnosed within 21 days prior to screening
- Females who are pregnant or breast feeding
- Acute hepatitis diagnosed within 21 days prior to screening
- Subjects receiving drug treatment for HCV or subjects anticipated to receive treatment for HCV during the course of the 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 |
|---|---|---|
| Tenofovir disoproxil/emtricitabine/rilpivirineAlso: eviplera, complera | Drug | eviplera (complera) |
| Tenofovir disoproxil/emtricitabine/efavirenzAlso: Atripla | Drug | atripla |
Primary outcome
depression (questionaire)
Time frame: 12 month
PHQ which is a validated questionaire for depression
anxiety (questionaire)
Time frame: 12 month
STAI which is a validated questionaire for anxiety
sleeping quality (questionaire)
Time frame: 12 month
a validated questionaire
7 secondary outcomes
Hopkins Verbal Learning Test - Revised (test result in numbers)
Time frame: 12 month
Satisfaction (scale)
Time frame: 12 month
viral load (copies/mL)
Time frame: 24 month
color trail test - 2 parts (test result in numbers)
Time frame: 12 month
grooved pegboard test (test result in numbers)
Time frame: 12 month
clock drawing test (test result in numbers)
Time frame: 12 month
CD4 cell count (number of cells per mm3)
Time frame: 12 month
Results and safety
The study was stopped early (reason given: no more participants taking atripla). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir disoproxil/emtricitabine/rilpivirine and Tenofovir disoproxil/emtricitabine/efavirenz in people with HIV, run by Sheba Medical Center at 1 site in Israel.
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 12 inclusion and 10 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: stopped early, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: no more participants taking atripla). Results are not available in the source record.
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?
depression (questionaire) (time frame: 12 month). The study lists 3 primary outcomes in all. 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 27 Apr 2017.