HIV InfectionsPhase 4DREAMNCT03067285

A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study

A Phase 4 study testing ELV/COBI/FTC/TAF and DTG/3TC/ABC + ELV/COBI/FTC/TAF in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 6 sites in Spain.

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

A phase IV, multicentre, randomised, open-label, pilot clinical trial designed to evaluate HIV-infected, aviremic patients who receive treatment with the combination of DTG/3TC/ABC and who have neuropsychiatric adverse effects that, in the opinion of the investigators, may be related to taking DTG/3TC/ABC, if they… 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?: ELV/COBI/FTC/TAF and DTG/3TC/ABC + ELV/COBI/FTC/TAF
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 6 sitesSpain
Study dates: 8 Sep 2017to 23 Apr 2019
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 > 18 years of age diagnosed with HIV using normal serology techniques.
Current antiretroviral therapy with DTG/3TC/ABC.
HIV viral load < 50 copies/mL for at least 12 weeks prior to signing the consent form [(]confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:
Symptoms of anxiety or depression
Insomnia or other sleep disturbances

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Headache
Cognitive complaints (attention, concentration or memory)
Alterations in behaviour (irritability, aggressiveness or agitation)
Dizziness of neurological or neurologically-mediated origin

Who cannot join

Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
History of active CNS infections
Active psychosis, major depression with psychotic symptoms or autolytic ideation
Dementia or mental retardation
Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria

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Illnesses that may interfere with the study procedures
Claustrophobia
Presence of magnetisable devices in the body
Inability to complete any of the study procedures
Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

Hospital Fundación Jimenez Díaz
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Univ. Infanta Leonor
Madrid
Hospital Univ. La Princesa
Madrid
Hospital Universitario La Paz
Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid

Other trials in Spain

About this study

Read the detailed description

we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.

Conditions: HIV Infections
Being tested: ELV/COBI/FTC/TAF, DTG/3TC/ABC + ELV/COBI/FTC/TAF
Medical subject headings: HIV Infections

What participants receive

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

ELV/COBI/FTC/TAFDrug
Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.
DTG/3TC/ABC + ELV/COBI/FTC/TAFDrug
Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks

Study groups in NCT03067285
Study group	Role	What they receive
Arm 1	Active comparator	Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks: Receives: Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF
Arm 2	Experimental	Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit Receives: Drug: ELV/COBI/FTC/TAF

What is being measured

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

To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale.
anxiety and depression scale.
Measured: Week 4
To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index.
Measured: Week 4
To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the depression scale.
Measured: Week 4

Secondary outcomes (7)

To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale.
Measured: Week 4
To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index
Measured: Week 4
To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale.
Measured: Week 4
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in levels of neuronal integrity estimated by determining N-acetylaspartate levels in the structures of the frontal lobe and the basal ganglia using spectroscopy.
Measured: Week 24 after the switching
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in the levels of white matter integrity estimated using the diffusion tensor imaging MRI technique.
Measured: Week 24 after the switching
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
To evaluate the change in global neurocognitive function (global deficit score) and cognitive domains (T-scores) in the volumes of the different structures of the brain using MRI volumetric techniques; the change in the levels of brain inflammation estimated by determining the levels of choline and myo-inositol in the structures of the frontal lobe and basal ganglia using spectroscopy.
Measured: Week 24 after the switching
Percentages of virologic failure
To evaluate the percentages of virologic failure after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF
Measured: Week 24 after the switching

Timeline

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

8 Sep 201723 Apr 2019

First posted1 Mar 2017
Study start8 Sep 2017
Primary completion23 Apr 2019
Study completion23 Apr 2019

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A phase IV, open-label, randomised, pilot clinical trial
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03067285
Sponsor's protocol ID: GESIDA 9016
Acronym: DREAM
Status last verified: Aug 2018
First submitted: 14 Feb 2017
Last updated: 5 Feb 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
ClinicalTrials.gov ID: NCT03067285
Acronym / sponsor ID: DREAM / GESIDA 9016
Conditions: HIV Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Fundacion SEIMC-GESIDAUniversity, hospital or other
Study start: 8 Sep 2017 (actual)
Primary completion: 23 Apr 2019 (actual)
Study completion: 23 Apr 2019 (actual)
First posted: 1 Mar 2017 (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.

Detailed description

we estimate that 64 participants will need to be enrolled in the study to demonstrate symptomatic improvement after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A phase IV, open-label, randomised, pilot clinical trial

Arm	Type	Receives
Arm 1	Active comparator	Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAFPatients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:
Arm 2	Experimental	Drug: ELV/COBI/FTC/TAFPatients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit

Who may qualify

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

Key inclusion criteria (10 listed)

Patient > 18 years of age diagnosed with HIV using normal serology techniques.
Current antiretroviral therapy with DTG/3TC/ABC.
HIV viral load < 50 copies/mL for at least 12 weeks prior to signing the consent form [(]confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both). If the patient has a recent routine blood test available (≤ 4 weeks) that includes determining HIV viral load, these results may be used for the screening visit. If this test is not available, or the test is more than four weeks old, viral load will be determined on the day of screening in order to confirm that the patient meets this criterion.
Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:

Key exclusion criteria (11 listed)

Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
History of active CNS infections
Active psychosis, major depression with psychotic symptoms or autolytic ideation
Dementia or mental retardation

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
ELV/COBI/FTC/TAFTreatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.	Drug	Arm 2
DTG/3TC/ABC + ELV/COBI/FTC/TAFPatients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks	Drug	Arm 1

Primary outcome

To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
Time frame: Week 4
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale. anxiety and depression scale.
To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
Time frame: Week 4
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the pittsburgh sleep quality index.
To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy.
Time frame: Week 4
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the depression scale.

7 secondary outcomes

To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
Time frame: Week 4
To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
Time frame: Week 4
To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
Time frame: Week 4
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
Time frame: Week 24 after the switching
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
Time frame: Week 24 after the switching
To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
Time frame: Week 24 after the switching
Percentages of virologic failure
Time frame: Week 24 after the switching

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 Feb 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.

The record lists no contact. Use the official record to reach the sponsor.

6 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 ELV/COBI/FTC/TAF and DTG/3TC/ABC + ELV/COBI/FTC/TAF in people with HIV Infections, run by Fundacion SEIMC-GESIDA at 6 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 10 inclusion and 11 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 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

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?

To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy. (time frame: Week 4). 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 NCT03067285.

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 Feb 2020.