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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Raltegravir||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, open, non-randomized pilot trial.|
|Masking:||None (Open Label)|
|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|
Raltegravir (RAL) x 2 600mg QD (Total 1200mg QD)
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
- 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
- Neuropsychiatric symptoms [ Time Frame: 24 weeks ]Presence and Intensity of neuropsychiatric symptoms (visual scale 0 to 10)
- 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
- 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
- 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.
- 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.
- 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.
- 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
- 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.
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
|Contact: Gloria Luque||+34 951 29 19 email@example.com|
|Contact: Alejandro Pérez||+34 951 29 14 firstname.lastname@example.org|
|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|
|Study Director:||Julian Olalla, PhD||SAS|