Gut microbiota, PGx and INSTIs response

Phase 1

• Conditions: HIV infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001103-17-BE
• Lead Sponsor: Cliniques universitaires Saint-Luc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

-HIV infected adult patient regularly followed at Centre de reference HIV of CUSL and currently treated by DTG (n=80) or 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 DTG (n=20) or BIC (n=20).
-HIV infected adult patient retrospectively identified as having stopped DTG due to NPAE (insomnia, depression, anxiety) (n=50). Identification will be based on the interrogation of our prospective clinical database.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified