An observational study in HIV+ Patients, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-27.
Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational
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.
Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 311 studies on the registry; 77 are open to participants now.
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HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.
Exclusion criteria:
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.
The presence of at least one of the following neurological or psychiatric disorders
* 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.
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Fondation Ophtalmologique Adolphe de Rothschild