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)

• Status: Completed
• Trial end date: 2020-06-25
• Target enrollment: 0
• Participant gender: All

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)

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

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Collaborator: Janssen-Cilag, S.A.
• Treatments: Abacavir; Cobicistat; Darunavir; Dolutegravir; Emtricitabine; Lamivudine; Tenofovir

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