Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT02529059
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2015-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
Sponsor:
St Stephens Aids Trust
Organization:
Study Overview
Official Title:
A Phase IV, Open-label, Multi Centre Pilot Study to Assess Changes in Cerebral Function Parameters in Patients Without Perceived Central Nervous System (CNS) Symptoms When Switched From a Fixed Dose Combination of Tenofovir/Emtricitabine/Efavirenz (Atripla®) to a Fixed Dose Combination of Tenofovir/Emtricitabine/Rilpivirine (Eviplera®)
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to investigate whether substitution of Efavirenz (EFV) as the Tenofovir/Emtricitabine/Efavirenz (TDF/FTC/EFV) fixed-dose combination (FDC) Atripla, with Rilpivirine as the tenofovir/emtricitabine/rilpivirine (TDF/FTC/RPV) fixed-dose combination (FDC) Eviplera, leads to resolution of covert Central Nervous System (CNS) toxicity associated with EFV, continued virological suppression and immunological reconstitution and whether this is associated with an improvement in quality of life, sleep, anxiety/depression and neurocognitive function; the impact of switch on adherence will also be investigated.
Detailed Description:
Protocol Summary
Study Title: SSAT 058 - A phase IV, open-label, multi centre pilot study to assess the prevalence of objective neurocognitive abnormality in patients without perceived Central Nervous System (CNS) symptoms on tenofovir/emtricitabine/efavirenz Atripla® and the effect of switching to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera®).
Proposed Sponsor: St Stephen's AIDS Trust
Chief Investigator: Dr Mark Nelson
Name of Investigational Product: Eviplera®
Name of Active Ingredients: Rilpivirine, tenofovir, emtricitabine
Name of Non Investigational Medicinal Product : NA
Name of Active Ingredients: NA
Phase of Study: Phase IV
Objectives: The objectives of this study are:
Primary objectives
* To describe prevalence pattern, in patients without self-perceived CNS symptoms related to tenofovir/emtricitabine/efavirenz, of the following parameters assessed at baseline:
* Objective neurocognitive function testing.
* Self-reported central nervous system symptoms by questionnaire
* Reported Sleep quality Secondary objectives
* change in measured neurocognitive parameters from baseline to week 4 and 24
* change in sleep scores from baseline to week 4 and 24
* change in symptoms related to CNS toxicity from baseline over 24 weeks
* change in magnetic resonance imaging (MRI) and spectroscopy of brain between baseline and week 24.
* the rate of maintained virological suppression at \<50 copies/ml at each visit over 24 weeks
* changes in fasting lipids from baseline over 24 weeks
* change in reported adherence from baseline and to week 24 in:
* adherence
* Quality of life
* Reported anxiety and depression
Study Design: Multi-centre, open-label, single pilot study of 24 weeks. Study visits will take place at screening, baseline (within 36 days of screening visit), weeks 4, 12 and 24.
Substudy of 10 volunteers - MRI scan at baseline and week 24
Indication: HIV-1-infection
Methodology:
* Neurocognitive function testing measured by computerised tasks.
* CNS symptoms and sleep quality determined by questionnaire.
* Changes in CNS metabolites by 1H-MR spectroscopy imaging.
Planned Sample Size: 40 (across 4 centres)
Summary of Eligibility Criteria: HIV-infected individuals on Atripla with a viral load \< 50 copies/mL and a CD4 count \> 50 cells/mm3.
Number of Study Centres: 4
Duration of Treatment: 24 weeks
Dose and Route of Administration: A single-pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily.
Primary Endpoint: Summary of overall prevalence and categorised descriptions of the following measures will be determined at baseline:
* Neurocognitive function scores calculated as composite scores and individual domains.
* Reported CNS symptoms assessed using questionnaire based on Summary of Product Characteristics (SPC) will be scored for severity and reported as both individual and composite scores.
* Sleep Quality assessed by questionnaire at baseline.
Secondary Endpoint:
* change in measured neurocognitive parameters from baseline to week 4 and 24
* change in sleep scores from baseline to week 4 and 24
* change in symptoms related to CNS toxicity from baseline over 24 weeks
* Change in magnetic resonance imaging and spectroscopy of brain between baseline and week 24.
* the rate of maintained virological suppression at \<50 copies/ml at each visit over 24 weeks
* changes in fasting lipids from baseline over 24 weeks
* change in reported adherence from baseline and to week 24 in:
* adherence
* Quality of life
* Reported anxiety and depression
Study Title: SSAT 058 - A phase IV, open-label, multi centre pilot study to assess the prevalence of objective neurocognitive abnormality in patients without perceived Central Nervous System (CNS) symptoms on tenofovir/emtricitabine/efavirenz Atripla® and the effect of switching to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera®).
Proposed Sponsor: St Stephen's AIDS Trust
Chief Investigator: Dr Mark Nelson
Name of Investigational Product: Eviplera®
Name of Active Ingredients: Rilpivirine, tenofovir, emtricitabine
Name of Non Investigational Medicinal Product : NA
Name of Active Ingredients: NA
Phase of Study: Phase IV
Objectives: The objectives of this study are:
Primary objectives
* To describe prevalence pattern, in patients without self-perceived CNS symptoms related to tenofovir/emtricitabine/efavirenz, of the following parameters assessed at baseline:
* Objective neurocognitive function testing.
* Self-reported central nervous system symptoms by questionnaire
* Reported Sleep quality Secondary objectives
* change in measured neurocognitive parameters from baseline to week 4 and 24
* change in sleep scores from baseline to week 4 and 24
* change in symptoms related to CNS toxicity from baseline over 24 weeks
* change in magnetic resonance imaging (MRI) and spectroscopy of brain between baseline and week 24.
* the rate of maintained virological suppression at \<50 copies/ml at each visit over 24 weeks
* changes in fasting lipids from baseline over 24 weeks
* change in reported adherence from baseline and to week 24 in:
* adherence
* Quality of life
* Reported anxiety and depression
Study Design: Multi-centre, open-label, single pilot study of 24 weeks. Study visits will take place at screening, baseline (within 36 days of screening visit), weeks 4, 12 and 24.
Substudy of 10 volunteers - MRI scan at baseline and week 24
Indication: HIV-1-infection
Methodology:
* Neurocognitive function testing measured by computerised tasks.
* CNS symptoms and sleep quality determined by questionnaire.
* Changes in CNS metabolites by 1H-MR spectroscopy imaging.
Planned Sample Size: 40 (across 4 centres)
Summary of Eligibility Criteria: HIV-infected individuals on Atripla with a viral load \< 50 copies/mL and a CD4 count \> 50 cells/mm3.
Number of Study Centres: 4
Duration of Treatment: 24 weeks
Dose and Route of Administration: A single-pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily.
Primary Endpoint: Summary of overall prevalence and categorised descriptions of the following measures will be determined at baseline:
* Neurocognitive function scores calculated as composite scores and individual domains.
* Reported CNS symptoms assessed using questionnaire based on Summary of Product Characteristics (SPC) will be scored for severity and reported as both individual and composite scores.
* Sleep Quality assessed by questionnaire at baseline.
Secondary Endpoint:
* change in measured neurocognitive parameters from baseline to week 4 and 24
* change in sleep scores from baseline to week 4 and 24
* change in symptoms related to CNS toxicity from baseline over 24 weeks
* Change in magnetic resonance imaging and spectroscopy of brain between baseline and week 24.
* the rate of maintained virological suppression at \<50 copies/ml at each visit over 24 weeks
* changes in fasting lipids from baseline over 24 weeks
* change in reported adherence from baseline and to week 24 in:
* adherence
* Quality of life
* Reported anxiety and depression
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: