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Unfavourable opinion of ethical comittee for Amendment Nr 3
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The frequency of neurological and psychiatric complaints for participants taking rilpivirine, elvitegravir, or dolutegravir reaches on average 20-30% during clinical trials. The inclusion and exclusion criteria for enrolling people living with HIV are at times so selective and the subsequent descriptions of minor or severe adverse events (AE's) so often imprecise and ambiguous that one cannot extrapolate these particular research results to practicing medicine. These adverse events negatively affect the patient's quality of life and ultimately his or her good adherence to treatments.
This study aims at assessing the prevalence and at describing the neurological and psychiatric adverse events related to these drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| exposition to the drugs | patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine |
| |
| patients non exposed to the drugs |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir | Drug | chemical dosage ARV |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of patients with neurologic and/or psychiatric adverse events | 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine |
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Inclusion Criteria:
Exclusion Criteria:
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HIV patients with a prescription of rilpivirine, elvitegravir, or dolutegravir (modification or initiation of an antiretroviral treatment) and non exposed HIV patients, who don't take these drugs.
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| Name | Affiliation | Role |
|---|---|---|
| Antoine MOULIGNIER, MD | Fondation Ophtalmologique A. de Rothschild | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| France | Paris | France |
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| ID | Term |
|---|---|
| C509700 | elvitegravir |
| C562325 | dolutegravir |
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