HIV Infections
Conditions
Keywords
Lenacapavir under compassionate access, France, Cohort
Brief 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
Detailed description
Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France
Interventions
None listed
Sponsors
Saint-Louis Hospital, Paris, France
Bichat Hospital
Saint Antoine University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202
Exclusion criteria
* Absence of visits with virological assessment subsequent to inclusion visit * Participant opposition to use of follow-up data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| incidence of side effects and laboratory abnormalities on LEN treatment | between week 26 and Week 52 |
| evolution of HIV-1 or HIV-2 RNA over time | between week 26 and Week 52 |
| evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time | between week 26 and Week 52 |
| Proportion of patients with capsid resistance mutations emergence at time of virological failure response) compared with initiation (D0) | 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 | Week 26 |
Countries
France
Outcome results
None listed