Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera (DeepSwitch)

Sheba Medical Center

Status and phase

Terminated

Phase 4

Conditions

HIV

Treatments

Drug: Tenofovir disoproxil/emtricitabine/efavirenz

Drug: Tenofovir disoproxil/emtricitabine/rilpivirine

Study type

Interventional

Funder types

Other

Identifiers

NCT02447016

SHEBA-14-1462-IL-SMC

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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