HIVPhase 4NCT02529059
SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
A Phase 4 study testing Eviplera in people with HIV, run by St Stephens Aids Trust at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Eviplera
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient volunteers who meet all of the following criteria are eligible for this trial:
- Is male or female aged 18 years or above
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Has been on Atripla for at least 12 weeks before enrolment
Show all 12Show fewer
- Has an undetectable HIV-plasma viral load at screening by local assay (single re-test allowed)
- Has a CD4 cell count at screening >50 cells/mm3
- Has an estimated glomerular filtration rate (MDRD) >50 ml/min.
- Has no significant CNS symptoms which may be attributable to EFV.
- If female and of childbearing potential, is using effective birth control methods (for example, hormonal contraceptive, condom, abstinence, IUD, as agreed by the investigator) and is willing to continue practising these birth control methods during the trial and for at least 30 days after the end of the trial. Note: Women who are postmenopausal for least 2 years, women with total hysterectomy, and women who have a tubal ligation are considered of non-childbearing potential
- If a heterosexually active male, he is using effective birth control methods and is willing to continue practising these birth control methods during the trial and until follow-up visit
Who cannot join
- Patients meeting 1 or more of the following criteria cannot be selected:
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs (e.g proton pump inhibitors )
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Patients can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
- Any investigational drug within 30 days prior to the trial drug administration
Show all 14Show fewer
- Has ever received rilpivirine in the past
- Any clinical evidence of baseline resistance mutations, prior to commencing antiretroviral therapy.
- Known allergy to lactose monohydrate, sunset yellow aluminium lake (E110), and patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
- Severe hepatic impairment (defined as Child-Pugh-Turcotte (CPT) Score C).
- If female, she is pregnant or breastfeeding
- Screening blood result with any grade 3/4 toxicity according to Division of AIDS (DAIDS) grading scale, except: asymptomatic grade 3 glucose, amylase or lipid elevation or asymptomatic grade 4 triglyceride elevation (re-test allowed).
- Any condition (including drug/alcohol abuse) or laboratory results which, in the investigator's opinion, interfere with assessments or completion of the trial.
- If participating in the MR Imaging substudy, any contraindications to magnetic resonance scanning according to local radiology guidelines (to be assessed by MR Spectroscopy Imaging Department)
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Brighton & Sussex University Hospitals Nhs Trust
Brighton
St. Mary's Hospital
London
St. Stephen's Centre
London
About this study
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®)
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.
Read the 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
- Conditions
- HIV
- Being tested
- Eviplera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvipleraDrug
Also called Rilpivirine, tenofovir, emtricitabine
A single-pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Switch from Atripla to Eviplera | Experimental | Not described Receives: Drug: Eviplera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity
As defined by the ACTG Adverse event scale and collected by CNS questionnaire.
Measured: 4 Weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the median number of grade 2-4 neuropsychiatric and CNS toxicity
As defined by the ACTG adverse event scale and collected by CNS questionnaire.
Measured: 4 Weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the median CNS score.
Derived from the sum of toxicity of all grades collected in the CNS questionnaire.
Measured: 4 Weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the change in sleep score using the Pittsburgh Sleep Questionnaire.
Measured: 4 Weeks compared to baseline
Secondary outcomes (15)
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 & 24 weeks compared to baseline, as measured by proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity.
As defined by the ACTG adverse event scale and collected by CNS questionnaire.
Measured: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by the median number of grade 2-4 neuropsychiatric and CNS toxicity.
As defined by the ACTG adverse event scale and collected by CNS questionnaire.
Measured: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by the median CNS score
Median CNS score is derived from the sum of toxicity of all grades collected in the CNS questionnaire.
Measured: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by change in sleep score using the Pittsburgh Sleep Questionnaire.
Measured: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and CNS parameters as measured by the change in the Hospital Anxiety and Depression Scale (HADS) at 4, 12 and 24 weeks as compared with baseline.
Measured: 4, 12 and 24 weeks compared to baseline
Proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24.
Measured: 4, 12 and 24 weeks compared to baseline
Proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24.
Measured: 4, 12 and 24 weeks compared to baseline
Change in CD4+ count at week 12 and 24 compared to baseline.
Measured: 12 and 24 weeks compared to baseline
Proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and proportion of patients with grade 2-4 non-CNS adverse events at 4, 12 and 24 weeks compared with baseline.
Measured: 4, 12 and 24 weeks compared to baseline
Change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after 4, 12 and 24 weeks compared with baseline.
Measured: 4, 12 and 24 weeks compared to baseline
Change in quality of life (as assessed by EQ-5D questionnaire) at 4, 12 and 24 weeks compared with baseline.
Measured: 4, 12 and 24 weeks compared to baseline
Change in neurocognitive function as determined by computerised neurocognitive assessment (no computerised cognitive testing at week 12)
Measured: 4, 12 and 24 weeks compared to baseline
Change in neurocognitive function as determined by Instrumental Activities of Daily Life (IADL) questionnaire
Measured: 4, 12 and 24 weeks compared to baseline
Change in adherence as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI) at 12 and 24 weeks compared with baseline.
Measured: 12 and 24 weeks compared to baseline
Change in cerebral MR-measurable imaging modalities at 24 weeks compared with baseline.
Measured: 24 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, Principal investigator, St Stephen's AIDs Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529059
- Sponsor's protocol ID
- SSAT058
- Status last verified
- Sep 2017
- First submitted
- 27 May 2015
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®)
- ClinicalTrials.gov ID
- NCT02529059
- Acronym / sponsor ID
- SSAT058
- Conditions
- HIV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Nov 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Switch from Atripla to Eviplera | Experimental | Drug: Eviplera |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Is male or female aged 18 years or above
- Has HIV-1 infection documented in their medical notes
- Has signed the Informed Consent Form voluntarily
- Is willing to comply with the protocol requirements
- Has been on Atripla for at least 12 weeks before enrolment
Key exclusion criteria (14 listed)
- Infected with HIV-2
- Using any concomitant therapy disallowed as per SPC for the study drugs (e.g proton pump inhibitors )
- Has acute viral hepatitis including, but not limited to, A, B, or C
- Has chronic hepatitis B and/or C with AST and/or ALT >5 x ULN Note: Patients can enter trial with chronic HBV if HBV-DNA undetectable at screen (and no detectable result in last 6 months) and with chronic HCV if not expected to require treatment during the trial period.
- Any investigational drug within 30 days prior to the trial drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EvipleraAlso: Rilpivirine, tenofovir, emtricitabineA single-pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily for 24 weeks. | Drug | Switch from Atripla to Eviplera |
Primary outcome
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity
Time frame: 4 Weeks compared to baseline
As defined by the ACTG Adverse event scale and collected by CNS questionnaire.
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the median number of grade 2-4 neuropsychiatric and CNS toxicity
Time frame: 4 Weeks compared to baseline
As defined by the ACTG adverse event scale and collected by CNS questionnaire.
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the median CNS score.
Time frame: 4 Weeks compared to baseline
Derived from the sum of toxicity of all grades collected in the CNS questionnaire.
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the change in sleep score using the Pittsburgh Sleep Questionnaire.
Time frame: 4 Weeks compared to baseline
15 secondary outcomes
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 & 24 weeks compared to baseline, as measured by proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity.
Time frame: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by the median number of grade 2-4 neuropsychiatric and CNS toxicity.
Time frame: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by the median CNS score
Time frame: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 12 and 24 weeks compared to baseline, as measured by change in sleep score using the Pittsburgh Sleep Questionnaire.
Time frame: 12 and 24 weeks compared to baseline
Change in neuropsychiatric and CNS parameters as measured by the change in the Hospital Anxiety and Depression Scale (HADS) at 4, 12 and 24 weeks as compared with baseline.
Time frame: 4, 12 and 24 weeks compared to baseline
Proportion of patients with undetectable viral load (by local assay) at weeks 4, 12 and 24.
Time frame: 4, 12 and 24 weeks compared to baseline
Proportion of patients with viral load below 400 copies/mL at weeks 4, 12 and 24.
Time frame: 4, 12 and 24 weeks compared to baseline
Change in CD4+ count at week 12 and 24 compared to baseline.
Time frame: 12 and 24 weeks compared to baseline
Proportion of patients with grade 2-4 laboratory adverse events (excluding lipids) and proportion of patients with grade 2-4 non-CNS adverse events at 4, 12 and 24 weeks compared with baseline.
Time frame: 4, 12 and 24 weeks compared to baseline
Change in mean fasting cholesterol (total, HDL, LDL and total:HDL ratio) and triglycerides after 4, 12 and 24 weeks compared with baseline.
Time frame: 4, 12 and 24 weeks compared to baseline
Change in quality of life (as assessed by EQ-5D questionnaire) at 4, 12 and 24 weeks compared with baseline.
Time frame: 4, 12 and 24 weeks compared to baseline
Change in neurocognitive function as determined by computerised neurocognitive assessment (no computerised cognitive testing at week 12)
Time frame: 4, 12 and 24 weeks compared to baseline
Change in neurocognitive function as determined by Instrumental Activities of Daily Life (IADL) questionnaire
Time frame: 4, 12 and 24 weeks compared to baseline
Change in adherence as measured by the adherence questionnaire: Medication Adherence Self-Report Inventory (M-MASRI) at 12 and 24 weeks compared with baseline.
Time frame: 12 and 24 weeks compared to baseline
Change in cerebral MR-measurable imaging modalities at 24 weeks compared with baseline.
Time frame: 24 weeks compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Nelson principal investigator
St Stephen's AIDs Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eviplera in people with HIV, run by St Stephens Aids Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neuropsychiatric and central nervous system (CNS) parameters after switching from Atripla to TDF/FTC/RPV at 4 weeks compared to baseline, as measured by the proportion of patients experiencing grade 2-4 neuropsychiatric and CNS toxicity (time frame: 4 Weeks compared to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.