CompletedNot Applicable

Gut Microbiota, PGx and INSTIs Response

Belgium180 participantsStarted 2021-03-10

Plain-language 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 dolutegravir or bictegravir-based combined antiretroviral therapy, that aims at understanding the individual response to dolutegravir and bictegravir, in terms of efficacy and toxicity.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Dolutegravir and bictegravir through concentration

Timeframe: 24 hours post last dose

Dolutegravir and bictegravir intracellular concentration

Timeframe: 24 hours post last dose

Viral replication

Timeframe: At least 3 months after the initiation of DTG/BIC

Microbiota profile under treatment

Timeframe: At least 6 months after the initiation of DTG/BIC

Change of microbiota profile

Timeframe: Baseline and at 6 months

Change in weight

Timeframe: Through study completion, an average of 1 year

Psychometric evaluation (Symptom-checklist-90-R)

Timeframe: At least 3 months after the initiation of DTG/BIC

Trial details

NCT IDNCT04805944

SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-31

View on ClinicalTrials.gov More HIV Infections trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dolutegravir and bictegravir through concentration

Timeframe: 24 hours post last dose

Dolutegravir and bictegravir intracellular concentration

Timeframe: 24 hours post last dose

Viral replication

Timeframe: At least 3 months after the initiation of DTG/BIC

Microbiota profile under treatment

Timeframe: At least 6 months after the initiation of DTG/BIC

Change of microbiota profile

Timeframe: Baseline and at 6 months

Change in weight

Timeframe: Through study completion, an average of 1 year

Psychometric evaluation (Symptom-checklist-90-R)

Timeframe: At least 3 months after the initiation of DTG/BIC