An interventional study of Stop of ART in HIV Seropositivity, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-09.
Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Other
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Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological, and immunological investigations and for bio-banking purposes.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.
The aim of this proof-of-concept study on adult (>18 and \<65 years old), chronically HIV-1 infected individuals with undetectable viremia for ≥10 years, undetectable HIV-DNA, CD4+≥500 cells/µL and no evidence of detectable residual viremia for ≥5 years is to evaluate the frequency of spontaneous control of virus replication after ART pausing for up to 12 months and to identify the virological and immunological markers associated with spontaneous control of viral replication.
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 clinical assessment (study visit) will include: the evaluation of CDC stage, height, weight, systolic and diastolic blood pressure and smoking status, 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, urine analysis].
Additional 30 mL of peripheral blood will be withdrawn at study visits and stored in a biobank for further investigations.
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 will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption.
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 (eCRF).
The study will include HIV-1 infected:
Exclusion Criteria:
The study will exclude HIV-1 infected subjects:
Patients willing to stop antiretroviral therapy will stop ART.The occurrence of two consecutive HIV-1 RNA values \>50 copies/mL or the occurrence of stage B or C AIDS-defining events will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption.
Other: Stop of ART
Patients willing to stop antiretroviral therapy will stop ART.The occurrence of two consecutive HIV-1 RNA values \>50 copies/mL or the occurrence of stage B or C AIDS-defining events will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption.
Patients who will not resume antiretroviral regimen
Cumulative proportion of patients who will not resume ART 12 months after IMAP (Monitored Antiretroviral Pause) due to 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.
Time frame: 12 month
Change in plasma viremia
Change in plasma viremia
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Change in plasma HIV-DNA
Change in plasma HIV-DNA
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Change in CD4+
Change in CD4+
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Change in CD4+/CD8+ ratio
Change in CD4+/CD8+ ratio
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Change in virological biomarkers
Change in virological biomarkers prior to ART interruption and/or at ART resumption
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Change in immunological biomarkers
Change in immunological biomarkers prior to ART interruption and/or at ART resumption
Time frame: 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 32, 40, 48 weeks thereafter or at ART resumption.
Plan to share: Yes — Congress and scientific pubblications
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele