EUCTR2018-001158-82-ES
Active, not recruiting
Phase 1
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 - DETOX
Fundación SEIMC-GESIDA0 sites110 target enrollmentAugust 2, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV
- Sponsor
- Fundación SEIMC-GESIDA
- Enrollment
- 110
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
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 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.
- •\* A positive screening test for sleep disorders detected using the sleep quality index (Pittsburgh ).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 110
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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.
- •\* 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.
Outcomes
Primary Outcomes
Not specified
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