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Active, Not Recruiting

NCT Number: NCT06289361

Cohort IMEA 070 -Lenacapavir Compassional

Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de la Côte Basque, Bayonne, France

Loading trial locations.

About this study

Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. proportion of participants with plasma HIV RNA < 50 copies/ml 26 weeks after first LEN injection

    Time frame: Week 26

Secondary outcomes

  1. incidence of side effects and laboratory abnormalities on LEN treatment

    Time frame: between week 26 and Week 52

  2. evolution of HIV-1 or HIV-2 RNA over time

    Time frame: between week 26 and Week 52

  3. evolution of CD4, CD8 lymphocyte counts and CD4/CD8 ratio over time

    Time frame: between week 26 and Week 52

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba

Other

Collaborators

  • Bichat Hospital
  • Institut National de la Santé Et de la Recherche Médicale, France
  • Saint Antoine University Hospital
  • Saint-Louis Hospital, Paris, France

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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