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

HIV-1-infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281459
• Other study ID #: SCT 4/7
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2020
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this study is to evaluate the impact of SCT on the quality of life of HIV infected adults by administering HIV Treatment Satisfaction Questionnaires (HIV-TSQs) to patients receiving SCT for at least 48 weeks and by comparing their answers to those of patients receiving standard 7-days-a-week ART with comparable therapeutic regimens.

This is an interventional study performed at the HIV outpatients clinics of the Infectious and Tropical Diseases department in Azienda Ospedaliera Universitaria Integrata of Verona (Italy).

During standard visits and after collecting their informed consent, the investigators will administer HIV-TSQs to 30 patients receiving 4-days-a-week of rilpivirine-containing regimens (either rilpivrine/emtricitabine/tenofovir alafenamide or rilpivirine + lamivudine/abacavir) and to 30 patients receiving the same regimens but 7-days-a-week.

For the first group, the investigators will consider patients who have switched to a SCT at least 48 weeks before administration of the questionnaire, and data on their viro-immunological status (HIV-RNA, CD4+ cells count and CD4+/CD8+ ratio) after the switch to SCT will be retrospectively collected as well.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: November 30, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• HIV-1-infection

Intervention

Other:
• HIV Treatment Satisfaction Questionnaire status
Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.

Locations

Country	Name	City	State
Italy	AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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

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. — View Citation

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. — View Citation

de Truchis P, Assoumou L, Landman R, Mathez D, Le Dû 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients' satisfaction with their treatment: HIVTSQs	The patients satisfaction will be assessed using HIVTSQs	immediately after outpatient visit
Secondary	Virological suppression in the SCT group	all the Viral Load (copies/ml) determinations in the 48 weeks before enrollment will be registered	48 weeks before enrollment
Secondary	CD4+ cells count and CD4+/CD8+ ratio in the SCT group	all the CD4+ cells and CD4+/CD8+ determinations in the 48 weeks before enrollment will be registered	48 weeks before enrollment