Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia (NCT03198325) | Clinical Trial Compass
CompletedNot Applicable
Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia
Italy18 participantsStarted 2016-07-27
Plain-language summary
Prospective, open-label, single arm, non-randomized, proof-of-concept study. Eligible patients will sign a written informed consent and will be followed-up at screening, baseline (ART interruption) and at 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
The study visits will include: general clinical assessment, routine laboratory tests including: creatinine, phosphorus, calcium, alkaline phosphatase, AST, ALT, fasting glucose, total cholesterol, HDL- and LDL-cholesterol, triglycerides, CD4+ cell count and CD4+/CD8+ ratio.
Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological, and immunological investigations and for bio-banking purposes.
During follow-up, the occurrence of two consecutive HIV-1 RNA values \>50 copies/mL or the occurrence of stage B or C AIDS-defining events or any serious non-AIDS clinical event at least potentially related to treatment interruption will be criteria for ART resumption.
All patients with HIV-RNA\<50 copies/mL at week 48 (end of the study) will resume their baseline ART regimen.
The main demographic, clinical and therapy information will be accurately recorded at the study visits in an electronic Case Report Form.
Who can participate
Age range
18 Years – 65 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:
The study will include HIV-1 infected:
* men and non-pregnant women,
* ≥18 and \<65 years-old,
* asking to stop therapy,
* with HIV-1 RNA\<50 copies/mL for ≥10 years,
* current CD4+≥500 cells/µL,
* HIV-DNA\<100 copies/106PBMCs,
* no evidence of detectable residual viremia for ≥5 years .
Exclusion Criteria:
The study will exclude HIV-1 infected subjects:
* significant risk of HIV transmission during IMAP (including evidence of not adopting effective contraception methods and women who wish to be pregnant) in the opinion of the investigator,
* pregnancy and breastfeeding,
* a documented pre-ART HIV-1 RNA\<200 copies/mL,
* reactive Hepatitis B virus (HBV) surface antigen,
* positive HCV-RNA at the time of screening,
* current AIDS defining event as defined in category C of the 'Centers for disease control and prevention (CDC)' clinical classification,
* previous diagnosis of diabetes,
* a previous diagnosis of cancer or major adverse cardiac events (MACE) and currently receiving chemotherapy or immuno-modulating agents at the time of screening,
* history of HIV-related thrombocytopenia,
* active renal disease defined as a glomerular filtration rate (calculated by MDRD equation) below 50 mL/min or the presence of HIV associated nephropathy in the past medical history,
* any condition, including psychiatric or psychological disorders that might interfere with adherence to study requirements or safety of the participant,
* prior use of any HIV vaccine and/o…
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
Patients who will not resume antiretroviral regimen