NCT04805944Completed
Gut Microbiota, PGx and INSTIs Response
Gut Microbiota, Pharmacogenetics and Integrase Strand Transfer Inhibitors Response
Source: ClinicalTrials.gov · Last updated 10 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 180 (actual)
- First submitted
- 8 Mar 2021
- Start date
- 10 Mar 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Diseases
- HIV
- NCT number
- NCT04805944
What you commit to
- Study type: Observational
- Participants enrolled: 180
- From 10 Mar 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Liver failure (Child-Pugh A, B or C)
Other
- Pregnancy at the time of inclusion or expected pregnancy within 12 months, for patients treated by DTG or BIC during the study
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.