Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia (APACHE Study)

NCT03198325 NA COMPLETED

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 Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological, and immunological investigations and for bio-banking purposes.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.

Details

Lead sponsor	IRCCS San Raffaele
Phase	NA
Status	COMPLETED
Enrolment	18
Start date	2016-07-27
Completion	2018-04

Conditions

• HIV Seropositivity

Interventions

• Stop of ART

Primary outcomes

• Patients who will not resume antiretroviral regimen — 12 month
  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.

Countries

Italy