Cytomegalovirus Infection in Patients With HIV-1 Infection (NCT04067869) | Clinical Trial Compass
CompletedPhase 3
Cytomegalovirus Infection in Patients With HIV-1 Infection
France392 participantsStarted 2010-02-16
Plain-language summary
The purpose of this study is to assess the level of CD4 and CD8 T cell activation in an observational cohort study of HIV-1 patients, virosuppressed on combined antiretroviral therapy (\< 50 copies/ml) for at least 2 years and to focus on two factors that could participate in this activation: cytomegalovirus infection and auto-immune disorders.
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:
* Patients included in the Aquitaine ANRS CO3 cohort aged 18 years or older (confirmed HIV-1 infection and at least one follow-up in the cohort),
* plasma HIV-1 RNA \<50 copies / ml for at least 24 months under a highly active antiretroviral combination (treatment comprising at least 3 antiretroviral drugs) modified or initiated between 2005 and 2008,
* Follow-up in one of the departments of Bordeaux University Hospital or Libourne Hospital,
* Free, informed and written consent, signed by the patient and the investigator (Consent of the Aquitaine CO3 Cohort and linked to this specific study).
Exclusion Criteria:
* Presence of 2 consecutive measurements of HIV RNA\> 50 copies / ml,
* History of immunotherapy treatments (interleukin-2),
* Hepatitis B or C co-infections,
* Pregnancy
* Breastfeeding
* Symptomatic infectious episode in progress.
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.
1This trial studied cytomegalovirus infection specifically in people with HIV-1 — does my current HIV and CMV status make this kind of research relevant to my own situation, and should I be getting tested for CMV if I haven't already?
2Since this was a Phase 3 trial that has now completed, has any data been published yet, and what did measuring 'systemic lymphocyte activation' actually tell researchers about how CMV affects the immune system in HIV patients like me?
3Given that this trial looked at immune system activity in people with both HIV-1 and CMV, does the combination of these two infections typically change how aggressively either one needs to be treated in my case?
4Are there standard-of-care treatments for CMV co-infection in HIV patients that are already well established, and would those be a better starting point for me compared to seeking out research-based options?
5Based on what this completed trial found about lymphocyte activation, is there anything my care team should be monitoring differently in my regular bloodwork or immune function tests?
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.