HIV InfectionsPhase 4NEARQDNCT03732625
Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
A Phase 4 study testing Raltegravir in people with HIV Infections, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
Trial summary
Open, multicenter, non randomized, single arm, pilot trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Raltegravir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- May 2019to Jan 2021
- 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.
- Infection with chronic HIV-1.
- On triple therapy antiretroviral therapy based on abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), whose third component is DTG in a dose of 50 mg / day.
- Presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the DAIDS scale.
- Written informed consent to participate in the study.
Who cannot join
- Pregnant women, nursing or of childbearing age who want to get pregnant.
- Concomitant use of any medication with potential risk of interaction with the therapy under study.
- Intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it.
- Subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study.
- Abuse of alcohol or any other substance that may interfere with adherence to treatment.
- Subjects who are participating in any other clinical study with the exception of those in which the treatment under study has been suspended for more than 12 weeks.
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- AIDS event at the time of diagnosis of HIV infection or in the 3 months prior to its inclusion
- Any other clinical condition or previous treatment that makes the subject unsuitable for the study or that compromises their ability to comply with the treatment dosing requirements.
- History of mental illness or diagnosis of neuropsychological symptoms prior to the use of DTG.
- Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC.
- Chronic liver disease in the cirrhosis phase (either by ultrasound criteria or fibroscan ≥ 14.5 KPa)
- Consumption of tobacco ≥ 20 cigarettes / day.
- Additional Exclusion Criteria (for patients recruited at the Costa del Sol Hospital in Marbella only):
- History or diagnosis of claustrophobia, or inability to lie flat on the back inside the positron emission tomograph or MRI chamber for a period of 20 minutes.
- Contraindication to perform an MRI, including the presence of a cardiac pacemaker or other electronic device or ferromagnetic metallic foreign bodies in vulnerable positions evaluated by a standard questionnaire prior to MRI.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clínic University Hospital
Barcelona, 08036
Esteban Martínez
San Carlos Clinical Hospital
Madrid, 28040
Vicente Estrada
Costa del Sol University Hospital
Marbella, Málaga, 29603
Esteban Pérez
About this study
Open, multicenter, non randomized, single arm, pilot trial.
Read the detailed description
Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
- Conditions
- HIV Infections
- Being tested
- Raltegravir
- Keywords
- HIV infection, neuropsychological adverse effects, Raltegravir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Substitution
DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir | Experimental | Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD) Receives: Drug: Raltegravir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events)
Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome
Measured: 12 weeks
Secondary outcomes (8)
Neuropsychiatric symptoms
Presence and Intensity of neuropsychiatric symptoms (visual scale 0 to 10)
Measured: 24 weeks
Interruptions of the medication for any reason
Interruptions of the medication due to adverse effects, virological failure, or any other reason
Measured: 24 weeks
Change in quality of life (WHOQoL-bref questionnaire)
World Health Organization Quality of Life: 1-100 in 4 domains. 100 best score
Measured: 24 weeks
Variation of the result in the Hospital, Anxiety and Depression (HAD) scale
Hospital, anxiety and depression: 0 y 7 indicates no case, between 8 \& 10 indicates doubtful case and scores of 11 and above are possibly anxiety and depression cases.
Measured: 24 weeks
Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale
Pittsburgh Sleep Quality Index: Score 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.
Measured: 24 weeks
Variation of the result in the Epworth scale
Diurnal drowsiness: If score is less than 6 points, daytime sleepiness is low or absent; between 7 and 8, is in the average of the population and if it is higher than 9 its drowsiness is excessive.
Measured: 24 weeks
Variation of the result in the COLUMBIA-SUICIDE SEVERITY RATING (CSSR) scale
COLUMBIA-SUICIDE SEVERITY RATING SCALE: progressive score depending of each question answer
Measured: 24 weeks
Magnetic Resonance Imagigng (MRI) analysis for 10 of the patients recruited at the Costa del Sol Hospital (pilot subestudy)
- Identify patterns of different metabolic marker 18F-fluorodeoxyglucose (18F-FDG) uptake in patients suffering from central nervous system toxicity in relation to the use of Dolutegravir after replacement with Raltegravir.
- Observe if the anatomic-functional pattern of these patients changes after the substitution of Dolutegravir by Raltegravir.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study startMay 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, open, non-randomized pilot trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Julian Olalla, PhD, Study director, SAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732625
- Sponsor's protocol ID
- FIMHCSBR-2017
- Acronym
- NEARQD
- Status last verified
- Dec 2018
- First submitted
- 2 Nov 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
- ClinicalTrials.gov ID
- NCT03732625
- Acronym / sponsor ID
- NEARQD / FIMHCSBR-2017
- Conditions
- HIV Infections
- Keywords
- HIV infection, neuropsychological adverse effects, Raltegravir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 6 Nov 2018 (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.
Open, multicenter, non randomized, single arm, pilot trial.
Detailed description
Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, open, non-randomized pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Raltegravir | Experimental | Drug: RaltegravirRaltegravir (RAL) x 2 600mg QD (Total 1200mg QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Infection with chronic HIV-1.
- On triple therapy antiretroviral therapy based on abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), whose third component is DTG in a dose of 50 mg / day.
- Presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the DAIDS scale.
- Written informed consent to participate in the study.
Key exclusion criteria (15 listed)
- Pregnant women, nursing or of childbearing age who want to get pregnant.
- Concomitant use of any medication with potential risk of interaction with the therapy under study.
- Intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it.
- Subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study.
- Abuse of alcohol or any other substance that may interfere with adherence to treatment.
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 |
|---|---|---|
| RaltegravirAlso: SubstitutionDTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study. | Drug | Raltegravir |
Primary outcome
Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events)
Time frame: 12 weeks
Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome
8 secondary outcomes
Neuropsychiatric symptoms
Time frame: 24 weeks
Interruptions of the medication for any reason
Time frame: 24 weeks
Change in quality of life (WHOQoL-bref questionnaire)
Time frame: 24 weeks
Variation of the result in the Hospital, Anxiety and Depression (HAD) scale
Time frame: 24 weeks
Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale
Time frame: 24 weeks
Variation of the result in the Epworth scale
Time frame: 24 weeks
Variation of the result in the COLUMBIA-SUICIDE SEVERITY RATING (CSSR) scale
Time frame: 24 weeks
Magnetic Resonance Imagigng (MRI) analysis for 10 of the patients recruited at the Costa del Sol Hospital (pilot subestudy)
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- 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.
Julian Olalla, PhD study director
SAS
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 Raltegravir in people with HIV Infections, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 3 sites in Spain.
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 5 inclusion and 15 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 15 Feb 2019. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gloria Luque (+34 951 29 19 77, gloria.luque@fimabis.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events) (time frame: 12 weeks). 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 15 Feb 2019.