Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia
Condition: HIV Seropositivity
MeSH terms: Viremia; HIV Seropositivity
Study type: Interventional

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      Additional 30 mL of peripheral blood will be withdrawn at study visits for further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.
    

Detailed description: 
      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).
    

Intervention name(s): Stop of ART
Intervention type(s): Other
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HIV-1