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Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03964584
Recruitment Status : Withdrawn (Low scientific relevance due to the marketing of new treatments, and expected inclusion difficulties)
First Posted : May 28, 2019
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:

The neurological and psychiatric adverse effects of antiretroviral drugs is a concern for clinicians and people living with HIV. In addition, clinical trials conducted prior to market authorization often have stric inclusion and exclusion criteria in terms of age, co-morbidity or co-medication, and the patients included in the studies are not always representative of the population for whom the drugs will be prescribed in real life. We propose a prospective cohort study to assess the occurrence of neurological and psychiatric adverse events in HIV+ patients starting an association with dolutegravir or bictegravir.

Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.


Condition or disease Intervention/treatment
HIV+ Patients Other: assessment of neurological and psychiatric disorders by self-administered questionnaires

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: assessment of neurological and psychiatric disorders by self-administered questionnaires
    Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.


Primary Outcome Measures :
  1. The presence of at least one of the following neurological or psychiatric disorders [ Time Frame: 6 months ]
    • depression, defined by a CES-D score ≥ 17 for men and ≥ 23 for women
    • anxiety, defined by a STAI score ≥ 56 (high anxiety); a score > 65 indicating very high anxiety;
    • pathological fatigue, defined by a score on the EMIF-SEP scale ≥ 45/100;
    • presence of a neurological symptom identified by the QES questionnaire.



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
Sampling Method:   Non-Probability Sample
Study Population
HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.
Criteria

Inclusion criteria:

  • Age ≥ 18 years
  • HIV-infected
  • Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir

Exclusion criteria:

  • Intolerance to dolutegravir or bictegravir
  • Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
  • Alcohol consumption >10 standard drinks/week
  • Active HCV coinfection
  • Pregnant or breastfeeding woman
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03964584    
Other Study ID Numbers: AMR_2019_1
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020
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
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
dolutegravir
dictegravir
Neurological disorder
Psychiatric disorder
HIV integrase Inhibitors
Adverse drug event