Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study

• Status: Unknown status
• Trial end date: 2021-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Open, multicenter, non randomized, single arm, pilot trial.

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

Details

• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Dolutegravir; Raltegravir Potassium

Criteria

Inclusion Criteria:

• Age ≥ 18 years.

• Infection with chronic HIV-1.

• On triple therapy antiretroviral therapy based on abacavir/lamivudine (ABC/3TC) or tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) or tenofovir alafenamide/emtricitabine (TAF/FTC), whose third component is DTG in a dose of 50 mg / day.

• Presence of neuropsychiatric symptoms (insomnia, sleep disturbances, reduced concentration, dizziness, headaches, depression, restlessness or nervousness) with an intensity ≥ 2 on the DAIDS scale.

• Written informed consent to participate in the study.

Exclusion criteria:

• Pregnant women, nursing or of childbearing age who want to get pregnant.

• Concomitant use of any medication with potential risk of interaction with the therapy under study.

• Intolerance, hypersensitivity or previous resistance to the therapy under study or presence of any contraindication of it.

• Subjects in therapy with immunosuppressants or chemotherapy with cytotoxics, including interferon and interleukin-2 at the time of their inclusion in the study.

• Abuse of alcohol or any other substance that may interfere with adherence to treatment.

• Subjects who are participating in any other clinical study with the exception of those in which the treatment under study has been suspended for more than 12 weeks.

• AIDS event at the time of diagnosis of HIV infection or in the 3 months prior to its inclusion

• Any other clinical condition or previous treatment that makes the subject unsuitable for the study or that compromises their ability to comply with the treatment dosing requirements.

• History of mental illness or diagnosis of neuropsychological symptoms prior to the use of DTG.

• Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC.

• Chronic liver disease in the cirrhosis phase (either by ultrasound criteria or fibroscan ≥ 14.5 KPa)

• Consumption of tobacco ≥ 20 cigarettes / day.

Additional Exclusion Criteria (for patients recruited at the Costa del Sol Hospital in Marbella only):

• History or diagnosis of claustrophobia, or inability to lie flat on the back inside the positron emission tomograph or MRI chamber for a period of 20 minutes.

• Contraindication to perform an MRI, including the presence of a cardiac pacemaker or other electronic device or ferromagnetic metallic foreign bodies in vulnerable positions evaluated by a standard questionnaire prior to MRI.