Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction

NCT04281459 | Completed

• 1 other identifier: SCT 4/7
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

With this study the investigators propose to evaluate the satisfaction of the patients receiving antiretroviral treatment for HIV infection with standard everyday scheme, compared to patients receiving the same treatment with short-cycles of 4 days a week.

Conditions

HIV-1-infection

Keywords

Short-cycle therapy; SCT; rilpivirine; HIVTSQs; patients' satisfaction

Outcome Measures

Primary Outcomes (1)

• Patients' satisfaction with their treatment: HIVTSQs

  The patients satisfaction will be assessed using HIVTSQs

  immediately after outpatient visit

Secondary Outcomes (2)

• Virological suppression in the SCT group

  48 weeks before enrollment

• CD4+ cells count and CD4+/CD8+ ratio in the SCT group

  48 weeks before enrollment

Study Arms (2)

SCT 4/7

EXPERIMENTAL

Patients receiving 3-drug antiretroviral therapy containing rilpivirine with short cycle scheme of 4 consecutive days on and 3 days off treatment

Other: HIV Treatment Satisfaction Questionnaire status

Control

ACTIVE COMPARATOR

Patients receiving 3-drug antiretroviral therapy containing rilpivirine with standard scheme of 7 days per week of treatment

Other: HIV Treatment Satisfaction Questionnaire status

Interventions

HIV Treatment Satisfaction Questionnaire status OTHER

Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.

Also known as: HIV-TSQs

Control; SCT 4/7

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV-1 chronic infection;
• therapy with three-drugs and standard dosage ART containing rilpivirine: either rilpivirine/emtricitabine/tenofovir alafenamide (Odefsey) or rilpivirine/lamivudine/abacavir;
• virological suppression (VL\<50 copies/ml) for at least 12 months before switching to SCT. One viral blip with VL\<200 copies/ml, followed by a second deterrmination after 30 days \<20 copies/ml is admitted;
• CD4+ cells count \>200/mmc;
• no evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; no history of previous failures with their ART regimens;
• ability to provide written informed consent.

You may not qualify if:

• evidence or history of viral resistances against NNRTIs, tenofovir, emtricitabine, abacavir and lamivudine; history of previous failures with their ART regimen;
• diagnosis of any opportunistic infection in the 2 weeks before enrollment;
• for women, ongoing pregnancy and lactation;
• history of HBV infection (positive anti-HBc antibodies, with negative anti-HBs antibodies);
• therapy with experimental drugs/chemotherapy/radiotherapy in the 12 weeks before enrolment;
• current abuse of drugs or alcohol.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi

Verona, 37134, Italy

Location

Related Publications (8)

• Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23. doi: 10.1310/hct0801-19.

  PMID: 17434845 BACKGROUND

• Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.

  PMID: 20442758 BACKGROUND

• BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.

  PMID: 27562743 BACKGROUND

• Rudy BJ, Sleasman J, Kapogiannis B, Wilson CM, Bethel J, Serchuck L, Ahmad S, Cunningham CK; Adolescent Trials Network for HIV/AIDS Interventions. Short-cycle therapy in adolescents after continuous therapy with established viral suppression: the impact on viral load suppression. AIDS Res Hum Retroviruses. 2009 Jun;25(6):555-61. doi: 10.1089/aid.2008.0203.

  PMID: 19534628 BACKGROUND

• Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.

  PMID: 25833895 BACKGROUND

• de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.

  PMID: 29186458 BACKGROUND

• Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.

  PMID: 16961550 BACKGROUND

• Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients (QUATUOR). Identification number: NCT03256422

  BACKGROUND

Study Officials

• Massimiliano Lanzafame, MD

  AOUI Verona - UOC Malattie Infettive e Tropicali

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: March 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: November 30, 2020
• Last Updated: July 30, 2021

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From start of recruitment onwards
• Access Criteria: by email to the main investigator

Locations

IT (1)