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UNKNOWNPHASE4

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

NCT03732625•Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+4 more criteria

Locations (3)

Costa del Sol University Hospital

Marbella, Málaga, Spain

Clínic University Hospital

Barcelona, Spain

San Carlos Clinical Hospital

Madrid, Spain

Key Dates

Start Date

May 1, 2019

Primary Completion Date

January 1, 2020

Completion Date

January 1, 2021

Last Updated

February 15, 2019

Enrollment

ESTIMATED participants

Conditions

HIV Infections

Interventions

Raltegravir

DRUG

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

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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