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/Emtricita

• Status: Completed
• Trial end date: 2019-04-23
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Treatments: Abacavir; Cobicistat; Dolutegravir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Lamivudine; Tenofovir

Criteria

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.