- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02447016
Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera (DeepSwitch)
April 25, 2017 updated by: Itsik Levi Dr, Sheba Medical Center
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eviplera (complera)
Tab eviplera QD
|
Other Names:
|
Active Comparator: atripla
Tab Atripla QD
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depression (questionaire)
Time Frame: 12 month
|
PHQ which is a validated questionaire for depression
|
12 month
|
anxiety (questionaire)
Time Frame: 12 month
|
STAI which is a validated questionaire for anxiety
|
12 month
|
sleeping quality (questionaire)
Time Frame: 12 month
|
a validated questionaire
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hopkins Verbal Learning Test - Revised (test result in numbers)
Time Frame: 12 month
|
a validated test for memory testing
|
12 month
|
Satisfaction (scale)
Time Frame: 12 month
|
Visual Analogue Scale (VAS)
|
12 month
|
viral load (copies/mL)
Time Frame: 24 month
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efficacy of treatment in keeping undetectable viral load
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24 month
|
color trail test - 2 parts (test result in numbers)
Time Frame: 12 month
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a line drawing test which connects points in a certain order.
It serves as a general neurocognitive function test
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12 month
|
grooved pegboard test (test result in numbers)
Time Frame: 12 month
|
a specific test which serves as a general neurocognitive function test and was validated in HIV patients
|
12 month
|
clock drawing test (test result in numbers)
Time Frame: 12 month
|
a general test for dementia
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12 month
|
CD4 cell count (number of cells per mm3)
Time Frame: 12 month
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efficacy of treatment in keeping CD4 count from falling after intervention
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12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
December 21, 2016
Study Completion (Actual)
December 21, 2016
Study Registration Dates
First Submitted
May 10, 2015
First Submitted That Met QC Criteria
May 13, 2015
First Posted (Estimate)
May 18, 2015
Study Record Updates
Last Update Posted (Actual)
April 27, 2017
Last Update Submitted That Met QC Criteria
April 25, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C9 Inhibitors
- Cytochrome P-450 CYP2C19 Inhibitors
- Tenofovir
- Emtricitabine
- Efavirenz
- Rilpivirine
Other Study ID Numbers
- SHEBA-14-1462-IL-SMC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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