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

NCT03732625 | Unknown Phase 4

• 1 other identifier: FIMHCSBR-2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

HIV Infections

Keywords

HIV infection; neuropsychological adverse effects; Raltegravir

Outcome Measures

Primary Outcomes (1)

• Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events)

  Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome

  12 weeks

Secondary Outcomes (8)

• Neuropsychiatric symptoms

  24 weeks

• Interruptions of the medication for any reason

  24 weeks

• Change in quality of life (WHOQoL-bref questionnaire)

  24 weeks

• Variation of the result in the Hospital, Anxiety and Depression (HAD) scale

  24 weeks

• Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale

  24 weeks

Study Arms (1)

Raltegravir

EXPERIMENTAL

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

Drug: Raltegravir

Interventions

Raltegravir 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.

Also known as: Substitution

Raltegravir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (3)

Costa del Sol University Hospital

Marbella, Málaga, 29603, Spain

Location

Clínic University Hospital

Barcelona, 08036, Spain

Location

San Carlos Clinical Hospital

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Raltegravir Potassium; Mutation, Missense

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Mutation; Genetic Variation; Genetic Phenomena

Study Officials

• Julian Olalla, PhD

  SAS

  STUDY DIRECTOR

Central Study Contacts

Gloria Luque

CONTACT

+34 951 29 19 77; gloria.luque@fimabis.org

Alejandro Pérez

CONTACT

+34 951 29 14 47; alejandro.perez@fimabis.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, open, non-randomized pilot trial.

Study Record Dates

• First Submitted: November 2, 2018
• First Posted: November 6, 2018
• Study Start: May 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 15, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)