Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02447016
• Date of registration: 10/05/2015
• Prospective Registration: No
• Primary sponsor: Sheba Medical Center
• Public title: Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera DeepSwitch
• Scientific title: Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence
• Date of first enrolment: May 2015
• Target sample size: 25
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02447016
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Israel

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV

Intervention(s)

Drug: Tenofovir disoproxil/emtricitabine/efavirenz

Drug: Tenofovir disoproxil/emtricitabine/rilpivirine

Primary Outcome(s)

depression (questionaire) [Time Frame: 12 month]

anxiety (questionaire) [Time Frame: 12 month]

sleeping quality (questionaire) [Time Frame: 12 month]

Secondary Outcome(s)

color trail test - 2 parts (test result in numbers) [Time Frame: 12 month]

Satisfaction (scale) [Time Frame: 12 month]

grooved pegboard test (test result in numbers) [Time Frame: 12 month]

Hopkins Verbal Learning Test - Revised (test result in numbers) [Time Frame: 12 month]

viral load (copies/mL) [Time Frame: 24 month]

CD4 cell count (number of cells per mm3) [Time Frame: 12 month]

clock drawing test (test result in numbers) [Time Frame: 12 month]

Secondary ID(s)

SHEBA-14-1462-IL-SMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors