Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual … (NCT04054089) | Clinical Trial Compass
CompletedPhase 4
Evaluating Inflammatory and Immunological Changes of HIV-positive Patients Switching to DTG Dual Regimen Compared to Those Switching to a Triple Drugs Regimen (B/F/TAF)
Italy66 participantsStarted 2020-01-23
Plain-language summary
Long-term side effects of antiretrovirals (ART) have led to the introduction in clinical practice of NRTI-sparing regimens as double- or mono- therapy and their use is now recommended in specific populations by International Guidelines. Indeed, based on the monitoring of surrogate markers of ART efficacy, most of these unconventional regimens, when used in switch studies, have shown to have a non-inferior virological efficacy and a good CD4 recovery compared to standard triple drug-based therapy.
At present, the best marker to evaluate the risk of developing of non-AIDS related events has not been determined. Interestingly, the analysis of the data of the investigator's and others cohorts have shown that, in contrast with recent data from ART-CC collaboration, a low CD4/CD8 ratio is a predictor of non-AIDS related events independently from CD4 cell count, while other studies have shown an association of this marker with non-AIDS defining cancers or, more recently, with pulmonary emphysema. Aim of the present study is to compare CD8 and CD4/CD8 slopes in patients switching with an undetectable viral load to the 2 regimens which will be more frequently used in clinical practice: i.e B/F/TAF and dolutegravir + lamivudine. Indeed, B/F/TAF is already a recommended regimen in all guidelines while dolutegravir + lamivudine is widely used in clinical practice.
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 criteria
. Age = 18 years
. The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
. Patients infected by HIV-1
. Patients under the first-line cART regimen with three antiretrovirals
. HIV-RNA \<=50 copies/mL for at least 12 months
. No previous virological failures/blips
. A female subject is eligible to enter the study if it is confirmed that she is:
. Male subjects must agree to utilize a highly effective method of contraception (as defined in Appendix 5) during heterosexual intercourse or be non-heterosexually active, or practice sexual abstinence from first dose throughout the study period and for 30 days following the last study drug dose.
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
1
CD8 slope and consequent CD4/CD8 ratio difference between the 2 arms
. Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
. Known hypersensitivity to B/F/TAF FDC tablets, DTG and 3TC, their metabolites, or formulation excipient
. Subjects receiving ongoing therapy with any of the following medications in the table below, including drugs not to be used with B, F, TAF, DTG and 3TC.
. Documented resistance to any of the study drugs
. Active, serious infection (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1.
. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with protocol requirements. -