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Clinical trial

Gut Microbiota, Pharmacogenetics and Integrase Strand Transfer Inhibitors Response

ID
Name
INSTI
Description
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 dolutegravir or bictegravir-based combined antiretroviral therapy, that aims at understanding the individual response to dolutegravir and bictegravir, in terms of efficacy and toxicity.
Trial arms
Trial start
2021-03-10
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Treatment
Dolutegravir
Dolutegravir treated patients will be included and samples (blood for pharmacokinetic, pharmacogenetic et metabolite profiling, stools for microbiota profiling) drawn at follow-up.
Arms:
DTG treated (A)
Bictegravir
Bictegravir treated patients will be included and samples (blood for pharmacokinetic, pharmacogenetic and metabolite profiling, stools for microbiota profiling) drawn at follow-up.
Arms:
BIC treated (B)
Dolutegravir
Patient having discontinued dolutegravir will be included and samples (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) drawn at follow-up.
Arms:
DTG discontinued due to neuropsychiatric adverse event (C)
Dolutegravir
Patients starting dolutegravir will be included and sampled both before (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) and after (blood for pharmacokinetic and metabolite profiling, stools for microbiota profiling) the start of dolutegravir
Arms:
Shifting to DTG (D)
Bictegravir
Patients starting bictegravir will be included and sampled both before (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) and after (blood for pharmacokinetic and metabolite profiling, stools for microbiota profiling) the start of bictegravir
Arms:
Shifting to BIC (E)
Size
180
Primary endpoint
Dolutegravir and bictegravir through concentration
24 hours post last dose
Dolutegravir and bictegravir intracellular concentration
24 hours post last dose
Viral replication
At least 3 months after the initiation of DTG/BIC
Microbiota profile under treatment
At least 6 months after the initiation of DTG/BIC
Change of microbiota profile
Baseline and at 6 months
Change in weight
Through study completion, an average of 1 year
Psychometric evaluation (Symptom-checklist-90-R)
At least 3 months after the initiation of DTG/BIC
Change of psychometric evaluation (Symptom-checklist-90-R)
Baseline and at 6 months
Psychometric evaluation (Pittsburgh Sleep Quality Index)
At least 3 months after the initiation of DTG/BIC
Change of psychometric evaluation (Pittsburgh Sleep Quality Index)
Baseline and at 6 months
Psychometric evaluation (Pichot's fatigue scale)
At least 3 months after the initiation of DTG/BIC
Change of psychometric evaluation (Pichot's fatigue scale)
Baseline and at 6 months
Psychometric evaluation (Hospital Anxiety and Depression Scale)
At least 3 months after the initiation of DTG/BIC
Change of psychometric evaluation (Hospital Anxiety and Depression Scale)
Baseline and at 6 months
Eligibility criteria
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)
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Stools'}, 'enrollmentInfo': {'count': 180, 'type': 'ACTUAL'}}
Updated at
2024-05-10

1 organization

2 products

1 indication

Organization
Cliniques Universitaires Saint-Luc
Product
Dolutegravir
Indication
HIV Infections
Product
Bictegravir