Clinical trial NCT02447016: Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera
Official title: Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: HIV
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: depression (questionaire)
timeFrame: 12 month
measure: anxiety (questionaire)
timeFrame: 12 month
measure: sleeping quality (questionaire)
timeFrame: 12 month
Secondary outcomes:
measure: Hopkins Verbal Learning Test - Revised (test result in numbers)
timeFrame: 12 month
measure: Satisfaction (scale)
timeFrame: 12 month
measure: viral load (copies/mL)
timeFrame: 24 month
measure: color trail test - 2 parts (test result in numbers)
timeFrame: 12 month
measure: grooved pegboard test (test result in numbers)
timeFrame: 12 month
measure: clock drawing test (test result in numbers)
timeFrame: 12 month
measure: CD4 cell count (number of cells per mm3)
timeFrame: 12 month
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: