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

Fundacion SEIMC-GESIDA

Status and phase: Completed; Phase 4

Conditions: HIV Infections

Treatments: Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF; Drug: ELV/COBI/FTC/TAF

Study type: Interventional

Funder types: Other

Identifiers

NCT03067285

GESIDA 9016

Details and patient eligibility

About

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 improve after switching antiretroviral therapy to the combination of ELV/COBI/FTC/TAF.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 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
• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Patients who postpone switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF four weeks:

Treatment:

Drug: DTG/3TC/ABC + ELV/COBI/FTC/TAF

Arm 2

Experimental group

Description:

Patients who switch from DTG/3TC/ABC to ELV/COBI/FTC/TAF during the baseline visit

Treatment:

Drug: ELV/COBI/FTC/TAF