HIV InfectionsNCT06289361
Cohort IMEA 070 -Lenacapavir Compassional
An observational study of HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 23 sites in France.
Trial summary
Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- How many people
- 58 participants
- Where
- 23 sitesFrance
- Study dates
- 1 Apr 2024to 30 Nov 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022
Who may be able to join
- Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202
Who cannot join
- Absence of visits with virological assessment subsequent to inclusion visit
- Participant opposition to use of follow-up data
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Centre Hospitalier de la Côte Basque
Bayonne, France, 64100
Hopital Avicenne
Bobigny, 93000
Hôpital Pellegrin - Service de Médecine Interne et Maladies Infectieuses
Bordeaux, 33000
Hopital Saint-Andre
Bordeaux, 33075
Hôpital Béclère
Clamart, France, 92140
Hopital Zobda Quitman
Fort-de-France, Martinique, 97261
Hopital Raymond Poincare
Garches, 92380
C.H.D de Vendee
La Roche-sur-Yon, 85925
Hôpital de la Rochelle
La Rochelle, France, 17000
André Mignot Hospital
Le Chesnay, 78150
Hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94270
Centre Hospitalier Bretagne Sud - Hôpital du Scorff
Lorient, 56100
Hôpital Max Fourestier
Nanterre, France, 92000
CHU de Nice
Nice, 06200
CHU La Source
Orléans, France, 45100
Hôpital Hotel Dieu
Paris, 75004
Hopital Saint Antoine
Paris, 75012
Groupe Hospitalier Pitié-Salpêtrière - Service de Maladies Infectieuses et Tropicales
Paris, 75013
Hopital Necker
Paris, 75015
Bichat Hospital
Paris, 75018
Hôpital Félix Guyon
Saint-Denis, LA Reunion, 97400
Delafontaine
Saint-Denis, 93200
Hopital Foch
Suresnes, 92150
About this study
Official title: Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023
Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023
Read the detailed description
Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France
- Conditions
- HIV Infections
- Keywords
- Lenacapavir under compassionate access, France, Cohort
- Medical subject headings
- HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
Measured: Week 26
Secondary outcomes (5)
incidence of side effects and laboratory abnormalities on LEN treatment
Measured: between week 26 and Week 52
evolution of HIV-1 or HIV-2 RNA over time
Measured: between week 26 and Week 52
evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time
Measured: between week 26 and Week 52
Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)
Measured: between Week 26 and Week 52
Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024
- Primary completion15 Apr 2024
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Louis Hospital, Paris, France, Bichat Hospital, Saint Antoine University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289361
- Sponsor's protocol ID
- IMEA 070
- Status last verified
- Oct 2024
- First submitted
- 26 Feb 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunovirological Follow-up and Safety of HIV-infected Patients Receiving Lenacapavir Under Compassionate Access in France Between 01/01/2021 and 12/31/2023
- ClinicalTrials.gov ID
- NCT06289361
- Acronym / sponsor ID
- IMEA 070
- Conditions
- HIV Infections
- Keywords
- Lenacapavir under compassionate access, France, Cohort
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'BaUniversity, hospital or other
- Collaborators
- Saint-Louis Hospital, Paris, France, Bichat Hospital, Saint Antoine University Hospital, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 1 Mar 2024 (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.
Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023
Detailed description
Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients already followed and identified in the centers and having received lenacapavir in compassionate access between January 01st, 2021 and December 20th, 2022
Key inclusion criteria (1 listed)
- Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202
Key exclusion criteria (2 listed)
- Absence of visits with virological assessment subsequent to inclusion visit
- Participant opposition to use of follow-up data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection
Time frame: Week 26
5 secondary outcomes
incidence of side effects and laboratory abnormalities on LEN treatment
Time frame: between week 26 and Week 52
evolution of HIV-1 or HIV-2 RNA over time
Time frame: between week 26 and Week 52
evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time
Time frame: between week 26 and Week 52
Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0)
Time frame: between Week 26 and Week 52
Determination by multivariate analysis of factors associated with virological success 26 weeks after the first LEN injection factors associated with virological control 26 weeks after the first LEN injection
Time frame: Week 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for HIV Infections
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
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.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections, run by Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba at 23 sites 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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection (time frame: Week 26). 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 26 Oct 2024.