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

NCT ID: NCT03732625

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-31
• Study Completion Date: 2021-01-31

Brief Summary

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

Detailed Description

Open, multicenter, non randomized, single arm, pilot trial. The study is aimed at patients infected with HIV in triple antiretroviral therapy based on Dolutegravir (DTG) who experience neuropsychological adverse effects related to the treatment. After signing the informed consent, DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.

Conditions

HIV Infections

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Raltegravir

Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD)

Group Type: EXPERIMENTAL

Raltegravir

Intervention Type: DRUG

DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.

Interventions

Raltegravir

DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.

Intervention Type: DRUG

Other Intervention Names

Substitution

Eligibility 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julian Olalla, PhD

Role: STUDY_DIRECTOR

SAS

Locations

Costa del Sol University Hospital

Marbella, Málaga, Spain

Clínic University Hospital

Barcelona, , Spain

San Carlos Clinical Hospital

Madrid, , Spain

Countries

Spain

Central Contacts

Gloria Luque

Role: CONTACT

gloria.luque@fimabis.org

+34 951 29 19 77

Alejandro Pérez

Role: CONTACT

alejandro.perez@fimabis.org

+34 951 29 14 47

Other Identifiers

FIMHCSBR-2017

Identifier Type: -

Identifier Source: org_study_id