Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera

NCT ID: NCT02447016

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-12-21

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.

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eviplera (complera)

Tab eviplera QD

Group Type: EXPERIMENTAL

Tenofovir disoproxil/emtricitabine/rilpivirine

Intervention Type: DRUG

atripla

Tab Atripla QD

Group Type: ACTIVE_COMPARATOR

Tenofovir disoproxil/emtricitabine/efavirenz

Intervention Type: DRUG

Interventions

Tenofovir disoproxil/emtricitabine/rilpivirine

Intervention Type: DRUG

Tenofovir disoproxil/emtricitabine/efavirenz

Intervention Type: DRUG

Other Intervention Names

eviplera, complera; Atripla

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Itsik Levi Dr

Head HIV/STDs unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-14-1462-IL-SMC

Identifier Type: -

Identifier Source: org_study_id