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

NCT02882230 | Terminated

• 1 other identifier: AMR_2016_13
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

exposition to the drugs

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

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

patients non exposed to the drugs

Interventions

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

chemical dosage ARV

exposition to the drugs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

France

Paris, France

Location

MeSH Terms

Interventions

elvitegravir; dolutegravir

Study Officials

• Antoine MOULIGNIER, MD

  Fondation Ophtalmologique A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 29, 2016
• Study Start: November 19, 2018
• Primary Completion: December 3, 2018
• Study Completion: January 15, 2019
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

FR (1)