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

F

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

Status and phase

Unknown
Phase 4

Conditions

HIV Infections

Treatments

Drug: Raltegravir

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03732625
FIMHCSBR-2017

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.
  • 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.

Trial design

50 participants in 1 patient group

Raltegravir
Experimental group
Description:
Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD)
Treatment:
Drug: Raltegravir

Trial contacts and locations

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Central trial contact

Gloria Luque; Alejandro Pérez

Data sourced from clinicaltrials.gov

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