HIVNEPALNCT02882230
Evaluation of Neurologic and Psychiatric Adverse Events of Several Antiretroviral Drugs in Real Life Setting
An observational study of HIV, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2018to 15 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- drugs addiction (except for amyl nitriles ("poppers") and cannabis)
- alcoholism
- co-infection with hepatitis C virus
- pregnant or breast feeding patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting
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
- Being tested
- prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravirDrug
chemical dosage ARV
| Study group | Role | What they receive |
|---|---|---|
| exposition to the drugs | patients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine Receives: Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir | |
| patients non exposed to the drugs | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with neurologic and/or psychiatric adverse events
Measured: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study start19 Nov 2018
- Primary completion3 Dec 2018
- Study completion15 Jan 2019
Why it stopped: Unfavourable opinion of ethical comittee for Amendment Nr 3
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Antoine MOULIGNIER, MD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882230
- Sponsor's protocol ID
- AMR_2016_13
- Acronym
- NEPAL
- Status last verified
- Feb 2020
- First submitted
- 22 Aug 2016
- Last updated
- 27 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Neurologic and Psychiatric Adverse Events of Rilpivirine, Elvitegravir, or Dolutegravir in a Real Life Setting
- ClinicalTrials.gov ID
- NCT02882230
- Acronym / sponsor ID
- NEPAL / AMR_2016_13
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unfavourable opinion of ethical comittee for Amendment Nr 3
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposition to the drugs | – | Drug: prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravirpatients treated with at least one of the following drugs: dolutegravir, elvitegravir and rilpivirine |
| patients non exposed to the drugs | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- drugs addiction (except for amyl nitriles ("poppers") and cannabis)
- alcoholism
- co-infection with hepatitis C virus
- pregnant or breast feeding patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravirchemical dosage ARV | Drug | exposition to the drugs |
Primary outcome
number of patients with neurologic and/or psychiatric adverse events
Time frame: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine
Results and safety
The study was stopped early (reason given: Unfavourable opinion of ethical comittee for Amendment Nr 3). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine MOULIGNIER, MD principal investigator
Fondation Ophtalmologique A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unfavourable opinion of ethical comittee for Amendment Nr 3). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with neurologic and/or psychiatric adverse events (time frame: 6 months after modification or initiation of a treatment with one of the following drugs: dolutegravir, elvitegravir ou la rilpivirine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2020.