Clinical trial NCT03685500: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag, S.A.
First posted: 2018-09-26
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A phase IV, multicentre, randomised, open-label, pilot clinical trial.
Primary purpose: TREATMENT

Brief 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)

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

Eligibility criteria: Inclusion Criteria:

* 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 ).

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
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
timeFrame: week 4
Secondary outcomes:
measure: 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
timeFrame: week 4
measure: 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
timeFrame: week 4
measure: Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
timeFrame: Week 4 and 8 after switching to TAF/FTC/DRV/c
measure: Changes in the severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
timeFrame: Week 4 and 8 after switching to TAF/FTC/DRV/c
measure: Proportion and severity of neuropsychiatric symptoms potentially associated with the use of ABC/3TC/DTG after switching to TAF/FTC/DRV/c
timeFrame: Week 4 and 8 after switching to TAF/FTC/DRV/c
measure: Percentage of virologic failure after switching antiretroviral therapy from ABC/3TC/DTG to TAF/FTC/DRV/c
timeFrame: Week 8 after switching to TAF/FTC/DRV/c
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Madrid
country: Spain
facility: Hospital Univ. 12 de Octubre
city: Madrid
country: Spain
facility: H. Univ. Príncipe de Asturias
city: Madrid
country: Spain
facility: Hospital Fundación Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: