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Clinical Trials/EUCTR2020-001103-17-BE
EUCTR2020-001103-17-BE
Active, not recruiting
Phase 1

Gut microbiota, pharmacogenetics and Integrase Strand Transfer Inhibitors response - INSTI

Cliniques universitaires Saint-Luc0 sites200 target enrollmentDecember 1, 2020
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DrugsBiktarvy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Cliniques universitaires Saint-Luc
Enrollment
200
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 1, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Not specified

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