Status:
COMPLETED
Gut Microbiota, PGx and INSTIs Response
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Brief Summary
This is an interventional phase IV trial enrolling HIV-infected patients treated by dolutegravir or bictegravir-based combined antiretroviral therapy, and patients with a planned shift to a dolutegrav...
Detailed Description
The main objective of our research project is to better define the inter-individual variability in terms of clinical and biological response towards Integrase Strand Transfer Inhibitors, an important ...
Eligibility Criteria
Inclusion
- Inclusion will be proposed to:
- HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and currently treated by 50mg OD of DTG (n=80) or 50mg OD of BIC (n=30).
- Virally controlled immunologically functional HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and shifting from another ARV class to a treatment containing 50mg OD of DTG (n=20) or 50mg OD of BIC (n=20).
- HIV infected adult patient retrospectively identified as having stopped standard dosage of DTG (ie. 50mg OD) due to NPAE (insomnia, depression, anxiety) (n=50). Identification will be based on the interrogation of our prospective clinical database.
- Exclusion Criteria:
- Pregnancy at the time of inclusion or expected pregnancy within 12 months, for patients treated by DTG or BIC during the study
- Liver failure (Child-Pugh A, B or C)
Exclusion
Key Trial Info
Start Date :
March 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04805944
Start Date
March 10 2021
End Date
December 31 2023
Last Update
May 10 2024
Active Locations (1)
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1
Cliniques universitaires Saint-Luc
Brussels, Belgium