Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera

NCT02447016 | Terminated Phase 4

• 1 other identifier: SHEBA-14-1462-IL-SMC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• depression (questionaire)

  PHQ which is a validated questionaire for depression

  12 month

• anxiety (questionaire)

  STAI which is a validated questionaire for anxiety

  12 month

• sleeping quality (questionaire)

  a validated questionaire

  12 month

Secondary Outcomes (7)

• Hopkins Verbal Learning Test - Revised (test result in numbers)

  12 month

• Satisfaction (scale)

  12 month

• viral load (copies/mL)

  24 month

• color trail test - 2 parts (test result in numbers)

  12 month

• grooved pegboard test (test result in numbers)

  12 month

Study Arms (2)

eviplera (complera)

EXPERIMENTAL

Tab eviplera QD

Drug: Tenofovir disoproxil/emtricitabine/rilpivirine

atripla

ACTIVE COMPARATOR

Tab Atripla QD

Drug: Tenofovir disoproxil/emtricitabine/efavirenz

Interventions

Tenofovir disoproxil/emtricitabine/rilpivirine DRUG

Also known as: eviplera, complera

eviplera (complera)

Tenofovir disoproxil/emtricitabine/efavirenz DRUG

Also known as: Atripla

atripla

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Interventions

Tenofovir; Emtricitabine, Rilpivirine, Tenofovir Drug Combination; Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Rilpivirine; Nitriles; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Drug Combinations; Pharmaceutical Preparations; Oxazines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head HIV/STDs unit

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

IL (1)