HIV-1-infectionPhase 3DOBINeuroNCT04155554
Neurological Monitoring in Patients Switching From Dolutegravir Based Regimen to Bictegravir Based Regimen
A Phase 3 study testing Bictegravir/emtricitabine/tenofovir alafenamide and Dolutegravir/lamivudine/abacavir in people with HIV-1-infection, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
Trial summary
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Bictegravir/emtricitabine/tenofovir alafenamide and Dolutegravir/lamivudine/abacavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 29 Jan 2020to Jul 2021
- Phase
- Phase 3
- 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
- HIV-1 infection
- HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)
- On treatment with dolutegravir/abacavir/lamivudine >6 months
Who cannot join
- Previous AIDS events
- Pregnancy or pregnancy plan
- Decompensated cirrhosis (B or C CPT status)
- Intake of alcohol, substances, other drugs that may affect neurocognitive performances
- Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
- Certified diagnosis of major depression, psychosis, history of suicidal attempts
Show all 12Show fewer
- Treatment with antidepressants or antipsychotic drugs
- History of virological failure with INSTIs
- Lack of knowledge of italian language
- Impossibility to obtain informed written consent
- HBsAg positivity
- Estimated glomerular filtration rate by CK-EPI <50 mL/min per 1.73 m2
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Barbara Rossetti
Siena, 53100
Barbara Rossetti, PhD, +393201437658, barbara.rossetti@ao-siena.toscana.it
Maurizio Zazzi, Prof, +390577233863, maurizio.zazzi@unisi.it
About this study
Official title: The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.
Read the detailed description
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure.
- Conditions
- HIV-1-infection
- Being tested
- Bictegravir/emtricitabine/tenofovir alafenamide, Dolutegravir/lamivudine/abacavir
- Keywords
- HIV, Neurocognitive functions, Neuropsychiatric side effects, Bictegravir, INSTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bictegravir/emtricitabine/tenofovir alafenamideDrug
Also called Biktarvy
Switch patients from dolutegravir/lamivudine/abacavir to bictegravir/emtricitabine/tenefovir alafenamide to study neuropsychiatric side effects and neurocognitive function
Dolutegravir/lamivudine/abacavirDrug
Also called Triumeq
Continuing dolutegravir/lamivudine/abacavir to study neuropsychiatric side effects and neurocognitive function
| Study group | Role | What they receive |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamide | Experimental | Patients with suppressed viral load switching from dolutegravur/lamivudina/abacavir (50/300/600 mg) 1 tablet OD to bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) 1 tablet OD Receives: Drug: Bictegravir/emtricitabine/tenofovir alafenamide |
| Dolutegravir/lamivudine/abacavir | Active comparator | Patients with suppressed viral load continuing dolutegravir/lamivudine/abacavir (50/300/600 mg) 1 tablet OD Receives: Drug: Dolutegravir/lamivudine/abacavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychiatric symptoms severity in 3 months
change in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).
Measured: 3 months
Secondary outcomes (9)
neuropsychiatric symptoms severity in 3 and 12 months
change in neuropsychiatric symptoms severity, each of the 10 symptoms analyzed separately using the Symptom Checklist-90-R, 3 and 12 months after switching to bictegravir or dolutegravir (on treatment analysis)
Measured: 12 months
Mini International Neuropsychiatric Interview Plus subscale for suicide risk
change in neuropsychiatric symptoms severity, using the Mini International Neuropsychiatric Interview Plus subscale for suicide risk, 3 and 12 months after switching to bictegravir or dolutegravir (on treatment analysis). Suicide risk (five questions, score range 0-33 points) in the last 30 days was classified as low (1-5), moderate (6-9), or high (10).
Measured: 12 months
neurocognitive performance
change in neurocognitive performance, using a comprehensive and validated neuropsychological battery, 12 months after switching to bictegravir or dolutegravir (on treatment analysis).
The neurocognitive performance is calculated by averaging the individual deficit scores from each neurocognitive test. Deficit scores for each test were calculated from age-, education-, -adjusted raw scores.
Measured: 12 months
neurocognitive impairment and neuropsychiatric symptoms
comparison of the inter-arm and intra-arm incidence of neurocognitive impairment (on the basis of Frascati criteria) at 12 months and neuropsychiatric symptoms (using the Symptom Checklist-90-R) at 3 (on treatment analysis) and 12 months (ITT-exposed, using LOCF)
Measured: 12 months
self-reported symptoms (21 items, 0-5 points for each), adherence (0-100%) and HR-QoL (9 items, 0-5 points for each)
changes in self-reported symptoms, adherence and HR-QoL (using validated questionnaires) during the first year of follow up (ITT-exposed, using LOCF).
Measured: 12 months
drug exposure
correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL during the first year of follow up (ITT-exposed, using LOCF).
Measured: 12 months
adverse events
proportion of adverse events and serious adverse events and of patients discontinuing due to side effects in both arms
Measured: 12 months
virological failures
proportion of virological failures and antiretrovirals resistance at virological failure
Measured: 12 months
Treatment Satisfaction
change in Treatment Satisfaction between arms as per specific questionnaire (TSQM Version 1.4, 15 questions, from 0 to 79 points as maximum)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start29 Jan 2020
- Primary completionAug 2020 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, Ospedale Policlinico San Martino, Azienda Ospedaliera San Paolo, Ospedale Amedeo di Savoia
- Responsible party
- Principal investigator, Barbara Rossetti, Azienda Ospedaliera Universitaria Senese
- Investigators
- Barbara Rossetti, PhD, Principal investigator, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155554
- Sponsor's protocol ID
- 2018-004885-32
- Other IDs
- 2018
- Acronym
- DOBINeuro
- Status last verified
- Jan 2020
- First submitted
- 5 Nov 2019
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Switching From Dolutegravir/Lamivudine/Abacavir (d/l/a) to Bictegravir/Emtricitabine/Tenofovir Alafenamide (b/f/Taf) in Patients With Suppressed Viral Load on Neuropsychiatric Side Effects and Neurocognitive Function
- ClinicalTrials.gov ID
- NCT04155554
- Acronym / sponsor ID
- DOBINeuro / 2018-004885-32
- Conditions
- HIV-1-infection
- Keywords
- HIV, Neurocognitive functions, Neuropsychiatric side effects, Bictegravir, INSTI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart, Ospedale Policlinico San Martino, Azienda Ospedaliera San Paolo, Ospedale Amedeo di Savoia
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 7 Nov 2019 (actual)
- 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.
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir.
Detailed description
Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit. The hypothesis of the present study is that bictegravir is associated with a lower incidence and severity of neuropsychiatric symptoms than dolutegravir. The main outcome measure will be a global severity index (GSI) of neuropsychiatric symptoms arising from 10 symptom domains, including somatization, obsessive-compulsiveness, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. The secondary outcomes are to compare, between arms and during follow up, neuropsychiatric symptoms severity, neurocognitive performance, changes in self-reported symptoms, adherence and HR-QoL, correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL, proportion of adverse events, proportion of virological failures and antiretrovirals resistance at virological failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized study (1: 1), open-label, controlled, phase 3, multicenter, non-profit
| Arm | Type | Receives |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamide | Experimental | Drug: Bictegravir/emtricitabine/tenofovir alafenamidePatients with suppressed viral load switching from dolutegravur/lamivudina/abacavir (50/300/600 mg) 1 tablet OD to bictegravir/emtricitabine/tenofovir alafenamide (50/200/25 mg) 1 tablet OD |
| Dolutegravir/lamivudine/abacavir | Active comparator | Drug: Dolutegravir/lamivudine/abacavirPatients with suppressed viral load continuing dolutegravir/lamivudine/abacavir (50/300/600 mg) 1 tablet OD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- HIV-1 infection
- HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/mL before screening, not confirmed)
- On treatment with dolutegravir/abacavir/lamivudine >6 months
Key exclusion criteria (12 listed)
- Previous AIDS events
- Pregnancy or pregnancy plan
- Decompensated cirrhosis (B or C CPT status)
- Intake of alcohol, substances, other drugs that may affect neurocognitive performances
- Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
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 |
|---|---|---|
| Bictegravir/emtricitabine/tenofovir alafenamideAlso: BiktarvySwitch patients from dolutegravir/lamivudine/abacavir to bictegravir/emtricitabine/tenefovir alafenamide to study neuropsychiatric side effects and neurocognitive function | Drug | Bictegravir/emtricitabine/tenofovir alafenamide |
| Dolutegravir/lamivudine/abacavirAlso: TriumeqContinuing dolutegravir/lamivudine/abacavir to study neuropsychiatric side effects and neurocognitive function | Drug | Dolutegravir/lamivudine/abacavir |
Primary outcome
neuropsychiatric symptoms severity in 3 months
Time frame: 3 months
change in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).
9 secondary outcomes
neuropsychiatric symptoms severity in 3 and 12 months
Time frame: 12 months
Mini International Neuropsychiatric Interview Plus subscale for suicide risk
Time frame: 12 months
neurocognitive performance
Time frame: 12 months
neurocognitive impairment and neuropsychiatric symptoms
Time frame: 12 months
self-reported symptoms (21 items, 0-5 points for each), adherence (0-100%) and HR-QoL (9 items, 0-5 points for each)
Time frame: 12 months
drug exposure
Time frame: 12 months
adverse events
Time frame: 12 months
virological failures
Time frame: 12 months
Treatment Satisfaction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Barbara Rossetti, PhD principal investigator
Azienda Ospedaliera Universitaria Senese
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bictegravir/emtricitabine/tenofovir alafenamide and Dolutegravir/lamivudine/abacavir in people with HIV-1-infection, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Barbara Rossetti, PhD (+393201437658, barbara.rossetti@ao-siena.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neuropsychiatric symptoms severity in 3 months (time frame: 3 months). 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 31 Jan 2020.