NCT02447016

Decrease of Neuropsychiatric Side Effects After Switching From Atripla to Eviplera

Decrease of Neuropsychiatric and Neurocognitive Side Effects Prevalence

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tenofovir disoproxil/emtricitabine/rilpivirine
DRUG	Tenofovir disoproxil/emtricitabine/efavirenz

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-21
• Completion: 2016-12-21
• First posted: 2015-05-18
• Last updated: 2017-04-27

Locations

1 site across 1 country: Israel