Monitored Antiretroviral Pause in Chronic HIV-Infected Subjects With Long-Lasting Suppressed Viremia
NCT ID: NCT03198325
Last Updated: 2024-02-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
18 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-07-27
Study Completion Date
2018-04-30
Brief Summary
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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Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological, and immunological investigations and for bio-banking purposes.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 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Additional 30 mL of peripheral blood will be withdrawn at study visits for further virological, and immunological investigations and for bio-banking purposes.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.
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Detailed Description
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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).
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).
Conditions
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HIV Seropositivity
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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Interruption of antiretroviral therapy
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.
Group Type
EXPERIMENTAL
Stop of ART
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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 .
* 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/or non-established experimental therapy,
* active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* 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/or non-established experimental therapy,
* active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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IRCCS San Raffaele
OTHER
Sponsor Role
lead
Responsible Party
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Castagna Antonella
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Ospedale San Raffaele Scientific Institute
Milan, , Italy
Site Status
Countries
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Italy
References
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Pau AK, George JM. Antiretroviral therapy: current drugs. Infect Dis Clin North Am. 2014 Sep;28(3):371-402. doi: 10.1016/j.idc.2014.06.001.
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Strategies for Management of Antiretroviral Therapy (SMART) Study Group; El-Sadr WM, Lundgren J, Neaton JD, Gordin F, Abrams D, Arduino RC, Babiker A, Burman W, Clumeck N, Cohen CJ, Cohn D, Cooper D, Darbyshire J, Emery S, Fatkenheuer G, Gazzard B, Grund B, Hoy J, Klingman K, Losso M, Markowitz N, Neuhaus J, Phillips A, Rappoport C. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 2006 Nov 30;355(22):2283-96. doi: 10.1056/NEJMoa062360.
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Strategies for Management of Antiretroviral Therapy (SMART) Study Group; Emery S, Neuhaus JA, Phillips AN, Babiker A, Cohen CJ, Gatell JM, Girard PM, Grund B, Law M, Losso MH, Palfreeman A, Wood R. Major clinical outcomes in antiretroviral therapy (ART)-naive participants and in those not receiving ART at baseline in the SMART study. J Infect Dis. 2008 Apr 15;197(8):1133-44. doi: 10.1086/586713.
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Strategies for Management of Antiretroviral Therapy (SMART) Study Group; Lundgren JD, Babiker A, El-Sadr W, Emery S, Grund B, Neaton JD, Neuhaus J, Phillips AN. Inferior clinical outcome of the CD4+ cell count-guided antiretroviral treatment interruption strategy in the SMART study: role of CD4+ Cell counts and HIV RNA levels during follow-up. J Infect Dis. 2008 Apr 15;197(8):1145-55. doi: 10.1086/529523.
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Saez-Cirion A, Bacchus C, Hocqueloux L, Avettand-Fenoel V, Girault I, Lecuroux C, Potard V, Versmisse P, Melard A, Prazuck T, Descours B, Guergnon J, Viard JP, Boufassa F, Lambotte O, Goujard C, Meyer L, Costagliola D, Venet A, Pancino G, Autran B, Rouzioux C; ANRS VISCONTI Study Group. Post-treatment HIV-1 controllers with a long-term virological remission after the interruption of early initiated antiretroviral therapy ANRS VISCONTI Study. PLoS Pathog. 2013 Mar;9(3):e1003211. doi: 10.1371/journal.ppat.1003211. Epub 2013 Mar 14.
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Gianotti N, Canducci F, Galli L, Cossarini F, Salpietro S, Poli A, Nozza S, Spagnuolo V, Clementi M, Sampaolo M, Ceresola ER, Racca S, Lazzarin A, Castagna A. HIV DNA loads, plasma residual viraemia and risk of virological rebound in heavily treated, virologically suppressed HIV-infected patients. Clin Microbiol Infect. 2015 Jan;21(1):103.e7-103.e10. doi: 10.1016/j.cmi.2014.08.004. Epub 2014 Oct 13.
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Mastrangelo A, Burbelo PD, Galli L, Poli A, Alteri C, Scutari R, Muccini C, Spagnuolo V, Caccia R, Turrini F, Bigoloni A, Galli A, Castagna A, Cinque P. Anti-HIV antibodies are representative of the latent reservoir but do not correlate with viral control in people with long-lasting virological suppression undergoing analytical treatment interruption (APACHE study). J Antimicrob Chemother. 2021 May 12;76(6):1646-1648. doi: 10.1093/jac/dkab060. No abstract available.
Reference Type
DERIVED
Other Identifiers
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APACHE Study
Identifier Type: -
Identifier Source: org_study_id
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