HIV+ PatientsNEPALENCT03964584
Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life
An observational study of HIV+ Patients, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV+ Patients
- What is being tested?
- assessment of neurological and psychiatric disorders by self-administered questionnaires
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Sep 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 infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.
Who may be able to join
- Age ≥ 18 years
- HIV-infected
- Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir
Who cannot join
- Intolerance to dolutegravir or bictegravir
- Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
- Alcohol consumption >10 standard drinks/week
- Active HCV coinfection
- Pregnant or breastfeeding woman
About this study
Official title: Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)
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.
- Conditions
- HIV+ Patients
- Being tested
- assessment of neurological and psychiatric disorders by self-administered questionnaires
- Keywords
- dolutegravir, dictegravir, Neurological disorder, Psychiatric disorder, HIV integrase Inhibitors, Adverse drug event
- Medical subject headings
- Nervous System Diseases, Mental Disorders, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of neurological and psychiatric disorders by self-administered questionnairesOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Why it stopped: Low scientific relevance due to the marketing of new treatments, and expected inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV+ PatientsStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964584
- Sponsor's protocol ID
- AMR_2019_1
- Acronym
- NEPALE
- Status last verified
- Feb 2020
- First submitted
- 24 May 2019
- Last updated
- 27 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Evaluation of the Neurological and Psychiatric Adverse Events of Dolutegravir and Bictegravir in Real Life (NEPALE)
- ClinicalTrials.gov ID
- NCT03964584
- Acronym / sponsor ID
- NEPALE / AMR_2019_1
- Conditions
- HIV+ Patients
- Keywords
- dolutegravir, dictegravir, Neurological disorder, Psychiatric disorder, HIV integrase Inhibitors, Adverse drug event
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Low scientific relevance due to the marketing of new treatments, and expected inclusion difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 28 May 2019 (actual)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV infected patients who need to initiate or modify antiretroviral therapy, and starting a combination of antiretroviral agents including dolutegravir or bictegravir.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- HIV-infected
- Initiation or modification of antiretroviral therapy, and starting a therapeutic combination including dolutegravir or bictegravir
Key exclusion criteria (5 listed)
- Intolerance to dolutegravir or bictegravir
- Addiction to a psychoactive product (drugs or medications) with the exception of amyl nitriles ("poppers") and occasional recreational cannabis
- Alcohol consumption >10 standard drinks/week
- Active HCV coinfection
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| assessment of neurological and psychiatric disorders by self-administered questionnairesPatients 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. | Other | – |
Primary outcome
The presence of at least one of the following neurological or psychiatric disorders
Time frame: 6 months
* 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for HIV+ Patients
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingObservational study
Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection
HIV
Recruiting
A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test
HIV1 Infection, HIV 2 Infection
Recruiting
Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being
Stigma, HIV
Not yet recruiting
Combating HIV Stigma in Healthcare Settings: A Standardized Patient Approach
Hiv
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV+ Patients, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 3 inclusion and 5 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: withdrawn, 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.
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 withdrawn before enrolling participants, so there are no results.
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?
The presence of at least one of the following neurological or psychiatric disorders (time frame: 6 months). 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.