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) (DETOX)

Fundacion SEIMC-GESIDA

Status and phase

Completed

Phase 4

Conditions

HIV Infections

Treatments

Drug: Symtuza® (TAF/FTC/DRV/c)

Drug: ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03685500

GESIDA 10418

Details and patient eligibility

About

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)

Full 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

Enrollment

78 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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