Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-01-15

Brief Summary

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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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Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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exposition to the drugs

patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine

prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

Intervention Type DRUG

chemical dosage ARV

patients non exposed to the drugs

No interventions assigned to this group

Interventions

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prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir

chemical dosage ARV

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* HIV infection
* age \> 18
* treatment with rilpivirine, elvitegravir, or dolutegravir (for exposed patients)
* treatment with none of these drugs (for non exposed patients)
* capacity of reading French language

Exclusion Criteria

* drugs addiction (except for amyl nitriles ("poppers") and cannabis)
* alcoholism
* co-infection with hepatitis C virus
* pregnant or breast feeding patient

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No