HIV InfectionsPhase 4DETOXNCT03685500

A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c)

A Phase 4 study testing Symtuza® (TAF/FTC/DRV/c) and ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) 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 to evaluate the Reversibility of abacavir/lamivudine/dolutegravir ( ABC/3TC/DTG) CNS-Related Neurotoxicity After Switching to tenofovir alafenamide/emtricitabine/darunavir/cobicistat (TAF/FTC/DRV/c) Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: HIV Infections
What is being tested?: Symtuza® (TAF/FTC/DRV/c) and ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: 6 sitesSpain
Study dates: 4 Dec 2018to 25 Jun 2020
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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.
Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks.
HIV viral load < 50 copies/mL for at least 24 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.
A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).

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 TAF/FTC/DRV/c.
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.
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.
Patient with documented intolerance or hypersensitivity to the study medication, or who has a contraindication to use it, according to the technical data sheet

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Spain6 sites

Hospital Univ. 12 de Octubre
Madrid, 28041
H. Univ. Príncipe de Asturias
Madrid
Hospital Fundación Jimenez Diaz
Madrid
Hospital Infanta Leonor
Madrid
Hospital Universitario La Paz
Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid

Other trials in Spain

About this study

Official title: Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat

Read the detailed description

The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c

Conditions: HIV Infections
Being tested: Symtuza® (TAF/FTC/DRV/c), ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Medical subject headings: HIV Infections

What participants receive

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

Symtuza® (TAF/FTC/DRV/c)Drug
Treatment with TAF/FTC/DRV/c during 8 weeks since randomized
ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)Drug
Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks

Study groups in NCT03685500
Study group	Role	What they receive
Arm 1	Active comparator	Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks Receives: Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)
Arm 2	Experimental	Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit Receives: Drug: Symtuza® (TAF/FTC/DRV/c)

What is being measured

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

Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
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 (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas
Measured: week 4

Secondary outcomes (6)

Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
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. Researchers will specifically ask the patient about eleven adverse effects at each visit. Each adverse effect will be documented and graduated, according to the criteria established in the "AIDS Clinical Trials Group (ACTG) Division of AIDS scale (2014)". Each adverse effect will be assigned a score between 0 and 3 points. The Score will include the individual scores for each of the eleven adverse effects collected, as well as the sum of all the individual scores presented by each patient at each study visit
Measured: week 4
Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
To compare, between the two arms of the study, changes in the percentage and in the severity of neuropsychiatric symptoms compiled using the hospital anxiety and depression scale. The scale includes 14 questions to evaluate the presence of depressive symptoms during the last week. Each question contains four answers with score between 0 and 3 points. To obtain the results of the questionnaire, the researcher must add the score obtained in the 7 questions of anxiety on the one hand and the 7 questions of depression on the other
Measured: week 4
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the ACTG adverse effects scale
Measured: Week 4 and 8 after switching to TAF/FTC/DRV/c
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
To evaluate the change in the percentage and in the severity of neuropsychiatric symptoms compiled using the Pittsburg sleep quality index (PSQI)
Measured: Week 4 and 8 after switching to TAF/FTC/DRV/c
Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
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 and 8 after switching to TAF/FTC/DRV/c
Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c
Virologic failure is defined as the presence of two consecutive HIV viral loads ≥ 50 copies/mL.
Measured: Week 8 after switching to TAF/FTC/DRV/c

Timeline

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

4 Dec 201825 Jun 2020

First posted26 Sep 2018
Study start4 Dec 2018
Primary completion25 Jun 2020
Study completion25 Jun 2020

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, multicentre, randomised, open-label, pilot clinical trial.
Masking: None (open label)
Enrolment: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03685500
Sponsor's protocol ID: GESIDA 10418
Acronym: DETOX
Status last verified: Jun 2022
First submitted: 8 Sep 2018
Last updated: 22 Jun 2022
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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IV, Open Label, Randomized, Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir Alafenamide/Emtricitabine/Darunavir/Cobicistat
ClinicalTrials.gov ID: NCT03685500
Acronym / sponsor ID: DETOX / GESIDA 10418
Conditions: HIV Infections
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Fundacion SEIMC-GESIDAUniversity, hospital or other
Collaborators: Janssen-Cilag, S.A.
Study start: 4 Dec 2018 (actual)
Primary completion: 25 Jun 2020 (actual)
Study completion: 25 Jun 2020 (actual)
First posted: 26 Sep 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.

Detailed description

The investigators estimate that 55 participants will need to be included per group, 110 patients in total, to demonstrate the benefit of switching ABC/3TC/DTG to TAF/FTC/DRV/c

Study design

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

Arm	Type	Receives
Arm 1	Active comparator	Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)Patients who postpone switching from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) four weeks
Arm 2	Experimental	Drug: Symtuza® (TAF/FTC/DRV/c)Patients who switch from ABC/3TC/DTG to Symtuza® (TAF/FTC/DRV/c) during the baseline visit

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient ≥ 18 years of age diagnosed with HIV using conventional serology techniques.
Current antiretroviral therapy with ABC/3TC/DTG for at least 4 weeks.
HIV viral load < 50 copies/mL for at least 24 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.
A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).

Key exclusion criteria (10 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 TAF/FTC/DRV/c.
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
Symtuza® (TAF/FTC/DRV/c)Treatment with TAF/FTC/DRV/c during 8 weeks since randomized	Drug	Arm 2
ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks	Drug	Arm 1

Primary outcome

Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
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 (PSQI). The PSQI contains 19 questions in total. These questions are combined to form seven areas with their corresponding score, each of which shows a range between 0 and 3 points. In all cases, a score of "0" indicates ease, while a score of 3 indicates medium difficulty, within their respective area. The score of the seven areas is finally added for a global score, which ranges from 0 to 21 points. "0" indicates ease of sleep and "21" severe difficulty in all areas

6 secondary outcomes

Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
Time frame: week 4
Changes in the severity of neuropsychiatric symptoms, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c
Time frame: week 4
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
Time frame: Week 4 and 8 after switching to TAF/FTC/DRV/c
Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c
Time frame: Week 8 after switching to TAF/FTC/DRV/c

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 22 Jun 2022.
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 Symtuza® (TAF/FTC/DRV/c) and ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c) 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 4 inclusion and 10 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 22 Jun 2022. 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?

Proportion of patients who self-reported insomnia, between HIV-suppressed patients who continue ABC/3TC/DTG and those who switched to TAF/FTC/DRV/c (time frame: week 4). 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 NCT03685500.

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 22 Jun 2022.