THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTIO
- Conditions
- HIV-1 infectionMedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2018-004885-32-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA SENESE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
-Age >18 years
-HIV-1 infection
-HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/ml before screening not confirmed)
-On treatment with dolutegravir/abacavir/lamivudine >6 months
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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
-Previous AIDS events
-Pregnancy or pregnancy plan
-Decompensated cirrhosis (Child B or C)
-Intake of alcohol, substances, other drugs that may affect neurocognitive performance
-Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
-Certified diagnosis of major depression, psychosis, history of suicidal attempts
-Treatment with antidepressants or antipsychotic drugs
-History of virological failure with integrase inhibitors
-Lack of knowledge of italian language
-Impossibility to obtain informed written consent
-HBsAg positivity
-Estimated glomerular filtration rate by CK-EPI <50 ml/min per 1.73m2
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method