Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera

HIV Clinical Trial

— DeepSwitch  

Official title:

Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02447016
• Other study ID #: SHEBA-14-1462-IL-SMC
• Status: Terminated
• Phase: Phase 4
• First received: May 10, 2015
• Last updated: April 25, 2017
• Start date: May 2015
• Est. completion date: December 21, 2016

Study information

• Verified date: April 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV

Intervention

Drug:
• Tenofovir disoproxil/emtricitabine/rilpivirine

• Tenofovir disoproxil/emtricitabine/efavirenz

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	depression (questionaire)	PHQ which is a validated questionaire for depression	12 month
Primary	anxiety (questionaire)	STAI which is a validated questionaire for anxiety	12 month
Primary	sleeping quality (questionaire)	a validated questionaire	12 month
Secondary	Hopkins Verbal Learning Test - Revised (test result in numbers)	a validated test for memory testing	12 month
Secondary	Satisfaction (scale)	Visual Analogue Scale (VAS)	12 month
Secondary	viral load (copies/mL)	efficacy of treatment in keeping undetectable viral load	24 month
Secondary	color trail test - 2 parts (test result in numbers)	a line drawing test which connects points in a certain order. It serves as a general neurocognitive function test	12 month
Secondary	grooved pegboard test (test result in numbers)	a specific test which serves as a general neurocognitive function test and was validated in HIV patients	12 month
Secondary	clock drawing test (test result in numbers)	a general test for dementia	12 month
Secondary	CD4 cell count (number of cells per mm3)	efficacy of treatment in keeping CD4 count from falling after intervention	12 month