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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03732625
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Brief Summary:
Open, multicenter, non randomized, single arm, pilot trial.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Raltegravir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicenter, open, non-randomized pilot trial.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Neuropsyquiatric Evolution After Introduction of Raltegravir QD in Substitution of Dolutegravir: NEAR QD Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Raltegravir
Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD)
Drug: 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.
Other Name: Substitution




Primary Outcome Measures :
  1. Evaluate improvement in neuropsychiatric symptoms at 12 weeks (Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events) [ Time Frame: 12 weeks ]
    Evaluate improvement in neuropsychiatric symptoms: grade 1 to 4 of DAIDS scale. higher values represent a worse outcome


Secondary Outcome Measures :
  1. Neuropsychiatric symptoms [ Time Frame: 24 weeks ]
    Presence and Intensity of neuropsychiatric symptoms (visual scale 0 to 10)

  2. Interruptions of the medication for any reason [ Time Frame: 24 weeks ]
    Interruptions of the medication due to adverse effects, virological failure, or any other reason

  3. Change in quality of life (WHOQoL-bref questionnaire) [ Time Frame: 24 weeks ]
    World Health Organization Quality of Life: 1-100 in 4 domains. 100 best score

  4. Variation of the result in the Hospital, Anxiety and Depression (HAD) scale [ Time Frame: 24 weeks ]
    Hospital, anxiety and depression: 0 y 7 indicates no case, between 8 & 10 indicates doubtful case and scores of 11 and above are possibly anxiety and depression cases.

  5. Variation of the result on the Pittsburgh Sleep Quality Index (PSQI) scale [ Time Frame: 24 weeks ]
    Pittsburgh Sleep Quality Index: Score 0 to 21 points. "0" indicates ease of sleeping and "21" severe difficulty in all areas.

  6. Variation of the result in the Epworth scale [ Time Frame: 24 weeks ]
    Diurnal drowsiness: If score is less than 6 points, daytime sleepiness is low or absent; between 7 and 8, is in the average of the population and if it is higher than 9 its drowsiness is excessive.

  7. Variation of the result in the COLUMBIA-SUICIDE SEVERITY RATING (CSSR) scale [ Time Frame: 24 weeks ]
    COLUMBIA-SUICIDE SEVERITY RATING SCALE: progressive score depending of each question answer

  8. Magnetic Resonance Imagigng (MRI) analysis for 10 of the patients recruited at the Costa del Sol Hospital (pilot subestudy) [ Time Frame: 24 weeks ]
    • Identify patterns of different metabolic marker 18F-fluorodeoxyglucose (18F-FDG) uptake in patients suffering from central nervous system toxicity in relation to the use of Dolutegravir after replacement with Raltegravir.
    • Observe if the anatomic-functional pattern of these patients changes after the substitution of Dolutegravir by Raltegravir.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732625


Contacts
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Contact: Gloria Luque +34 951 29 19 77 gloria.luque@fimabis.org
Contact: Alejandro Pérez +34 951 29 14 47 alejandro.perez@fimabis.org

Locations
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Spain
Costa del Sol University Hospital
Marbella, Málaga, Spain, 29603
Principal Investigator: Esteban Pérez         
Clínic University Hospital
Barcelona, Spain, 08036
Principal Investigator: Esteban Martínez         
San Carlos Clinical Hospital
Madrid, Spain, 28040
Principal Investigator: Vicente Estrada         
Sponsors and Collaborators
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Julian Olalla, PhD SAS

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Responsible Party: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03732625    
Other Study ID Numbers: FIMHCSBR-2017
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
HIV infection
neuropsychological adverse effects
Raltegravir
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action