Impaired CognitionPhase 4SWEARNCT02042001

Switching From Efavirenz/Atripla to Rilpivirine Among Patients With Neurocognitive or Neuropsychological Side Effects

A Phase 4 study testing Immediate switch to TDF/FTC/RPV and Switch to TDF/FTC/RPV after 24 weeks in people with Impaired Cognition and Depression/Anxiety, run by Azienda Ospedaliera San Gerardo di Monza at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Impaired Cognition, Depression/Anxiety, Poor Quality Sleep
What is being tested?: Immediate switch to TDF/FTC/RPV and Switch to TDF/FTC/RPV after 24 weeks
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 5 sitesItaly
Study dates: 1 Jul 2015to 15 Jan 2018
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

Age ≥18 years old and ability to sign informed consent
Continuative treatment with TDF/FTC/EFV for ≥180 days
HIV-1 RNA viral load < 50 copies/mL in two consecutive determinations (including screening)
No history of treatment failure and/or evidence of any mutations associated with resistance to NRTI or NNRTI
No contraindication to treatment with study drugs
Any one of the following conditions:
Altered scores in depression, quality of sleep or anxiety tests (ii) Alteration in 1 or more domains as assessed by neuropsychological assessment

Who cannot join

Ongoing treatment or predictable need of treatment with proton pump inhibitors
New AIDS defining condition diagnosed within the 21 days prior to screening
Previous diagnosis of AIDS dementia complex
Current alcohol or substance dependence
Major psychiatric disorders
Decompensated cirrhosis

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Plasma creatinine >1.2 mg/dl or estimated glomerular filtration rate <60 ml/min (MDRD formula)
AST, ALT or plasma bilirubin >3 times upper limit of normal
Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing/food requirements

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Italy5 sites

Spedali Civili - University of Brescia
Brescia
Clinica di Malattie Infettive, Ospedale San Martino
Genova
AO San Paolo - University of Milan
Milan
Clinic of Infectious Diseases, AO San Gerardo
Monza, MB, 20900
Ospedale Amedeo di Savoia - University of Turin
Torino

Other trials in Italy

About this study

Official title: A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among Virologically Suppressed, HIV-1 Infected Subjects With Mild or Asymptomatic EFV-related Neurocognitive or Neuropsychological Side Effects

Despite long-term use in clinical practice, chronic treatment with efavirenz (EFV) has been associated with persistent central nervous system symptoms or mild or even asymptomatic neurocognitive impairment. Whether switching to rilpivirine (RPV) containing regimen is beneficial among patients who experience mild or asymptomatic neurocognitive/neuropsychiatric adverse events during EFV has not been explored yet.

The proposed pilot study will examine whether switching from single tablet regimen TDF/FTC/EFV to single tablet regimen TDF/FTC/RPV is associated with neurocognitive/neuropsychiatric improvement among HIV-infected patients with mild/asymptomatic neurocognitive impairment or neuropsychiatric symptoms during EFV-containing antiretroviral treatment.

Patients under stable treatment with TDF/FTC/EFV, confirmed HIV-1 RNA viral load < 50 copies/mL and altered scores in depression, quality of sleep or anxiety tests and/or alteration in 1 or more domains as assessed by neuropsychological assessment, will be randomized to immediate or deferred (24 weeks) switch to TDF/FTC/RPV. Neurocognitive and neuropsychiatric tests will be repeated after 12, 24 and 48 weeks of follow-up and variations will be compared between groups.

Conditions: Impaired Cognition, Depression/Anxiety, Poor Quality Sleep, Quality of Life, HIV-1 Infection
Being tested: Immediate switch to TDF/FTC/RPV, Switch to TDF/FTC/RPV after 24 weeks
Medical subject headings: Cognition Disorders, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Immediate switch to TDF/FTC/RPVDrug
Also called Eviplera (r)
Switch to TDF/FTC/RPV after 24 weeksDrug
Also called Eviplera(r)
Patients will continue current EFV-containing regimen up to week 24 and then will be switched to TDF/FTC/RPV

Study groups in NCT02042001
Study group	Role	What they receive
Immediate Switch	Experimental	Immediate switch to TDF/FTC/RPV Receives: Drug: Immediate switch to TDF/FTC/RPV
Deferred Switch	Active comparator	Switch to TDF/FTC/RPV after 24 weeks Receives: Drug: Switch to TDF/FTC/RPV after 24 weeks

What is being measured

The primary outcome is the main question the study is designed to answer.

Neuropsychiatric side effects
Proportion of patients with improvement in depression, anxiety or quality of sleep scores, evaluated either as a binary (Yes/No) or on a continuous scale
Measured: 24 weeks
Neurocognitive side effects
- Proportion of patients with improvement in neurocognitive performances in either one of the 7 domains investigated, evaluated either as a binary (Abnormal/Normal) or on a continuous scale (deficit score)
Measured: 24 weeks
Composite neuropsychiatric/neurocognitive
Proportion of patients with improvement in either one of the previous binary end-point (composite end-point)
Measured: 24 weeks

Secondary outcomes (7)

Symptoms
Proportion of patients with self-reported improvement in treatment-related symptoms
Measured: 24 weeks
Quality of Life
Proportion of patients with self-reported improvement in quality of life
Measured: 24 weeks
Cognitive failure
Proportion of patients with improvement in Cognitive Failure Questionnaire
Measured: 24 weeks
Viral suppression
Proportion of patients with HIV-RNA <50 copies/ml after 12 weeks of treatment (ITT-M=F)
Measured: 12 weeks
Viral failure
Proportion of patients with HIV-RNA <400 copies/ml after 12 weeks (ITT-M=F)
Measured: 12 weeks
Virological efficacy
Proportion of patients with HIV-RNA <50 copies/ml after 24 weeks (ITT-M=F)
Measured: 24 weeks
Safety & Tolerability
Proportion of patients discontinuing treatment for intolerance to study drugs or due to side effects
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201515 Jan 2018

First posted22 Jan 2014 (estimated)
Study start1 Jul 2015
Primary completion3 Jul 2017
Study completion15 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Impaired CognitionStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02042001
Sponsor's protocol ID: IN-IT-264-1331
Acronym: SWEAR
Status last verified: Aug 2014
First submitted: 20 Jan 2014
Last updated: 5 Jul 2018
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Randomized Controlled Trial of Switch to Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus Continue TDF/FTC/Efavirenz (EFV) Treatment Among Virologically Suppressed, HIV-1 Infected Subjects With Mild or Asymptomatic EFV-related Neurocognitive or Neuropsychological Side Effects
ClinicalTrials.gov ID: NCT02042001
Acronym / sponsor ID: SWEAR / IN-IT-264-1331
Conditions: Impaired Cognition, Depression/Anxiety, Poor Quality Sleep, Quality of Life, HIV-1 Infection
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: 1 Jul 2015 (actual)
Primary completion: 3 Jul 2017 (actual)
Study completion: 15 Jan 2018 (actual)
First posted: 22 Jan 2014 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Immediate Switch	Experimental	Drug: Immediate switch to TDF/FTC/RPVImmediate switch to TDF/FTC/RPV
Deferred Switch	Active comparator	Drug: Switch to TDF/FTC/RPV after 24 weeksSwitch to TDF/FTC/RPV after 24 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age ≥18 years old and ability to sign informed consent
Continuative treatment with TDF/FTC/EFV for ≥180 days
HIV-1 RNA viral load < 50 copies/mL in two consecutive determinations (including screening)
No history of treatment failure and/or evidence of any mutations associated with resistance to NRTI or NNRTI
No contraindication to treatment with study drugs

Key exclusion criteria (9 listed)

Ongoing treatment or predictable need of treatment with proton pump inhibitors
New AIDS defining condition diagnosed within the 21 days prior to screening
Previous diagnosis of AIDS dementia complex
Current alcohol or substance dependence
Major psychiatric disorders

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
Immediate switch to TDF/FTC/RPVAlso: Eviplera (r)	Drug	Immediate Switch
Switch to TDF/FTC/RPV after 24 weeksAlso: Eviplera(r)Patients will continue current EFV-containing regimen up to week 24 and then will be switched to TDF/FTC/RPV	Drug	Deferred Switch

Primary outcome

Neuropsychiatric side effects
Time frame: 24 weeks
Proportion of patients with improvement in depression, anxiety or quality of sleep scores, evaluated either as a binary (Yes/No) or on a continuous scale
Neurocognitive side effects
Time frame: 24 weeks
- Proportion of patients with improvement in neurocognitive performances in either one of the 7 domains investigated, evaluated either as a binary (Abnormal/Normal) or on a continuous scale (deficit score)
Composite neuropsychiatric/neurocognitive
Time frame: 24 weeks
Proportion of patients with improvement in either one of the previous binary end-point (composite end-point)

7 secondary outcomes

Symptoms
Time frame: 24 weeks
Quality of Life
Time frame: 24 weeks
Cognitive failure
Time frame: 24 weeks
Viral suppression
Time frame: 12 weeks
Viral failure
Time frame: 12 weeks
Virological efficacy
Time frame: 24 weeks
Safety & Tolerability
Time frame: 24 weeks

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 5 Jul 2018.

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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.

Giuseppe Lapadula, MD, PhD principal investigator

AO San Gerardo of Monza

Andrea Gori, MD study director

AO San Gerardo of Monza

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 9 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. 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?

Neuropsychiatric side effects (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02042001.

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 5 Jul 2018.