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

Sponsor
Azienda Ospedaliera Universitaria Integrata Verona (Other)
Overall Status
Completed
CT.gov ID
NCT04281459
Collaborator
(none)
33
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: HIV Treatment Satisfaction Questionnaire status
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
Actual Study Start Date :
Mar 1, 2020
Actual Primary Completion Date :
Jun 1, 2020
Actual Study Completion Date :
Nov 30, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: SCT 4/7

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

    		•
    Active Comparator: Control

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Patients' satisfaction with their treatment: HIVTSQs [immediately after outpatient visit]

      The patients satisfaction will be assessed using HIVTSQs

    Secondary Outcome Measures

    1. Virological suppression in the SCT group [48 weeks before enrollment]

      all the Viral Load (copies/ml) determinations in the 48 weeks before enrollment will be registered

    2. CD4+ cells count and CD4+/CD8+ ratio in the SCT group [48 weeks before enrollment]

      all the CD4+ cells and CD4+/CD8+ determinations in the 48 weeks before enrollment will be registered

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi Verona Italy 37134

    Sponsors and Collaborators

    • Azienda Ospedaliera Universitaria Integrata Verona

    Investigators

    • Principal Investigator: Massimiliano Lanzafame, MD, AOUI Verona - UOC Malattie Infettive e Tropicali

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Azienda Ospedaliera Universitaria Integrata Verona
    ClinicalTrials.gov Identifier:
    NCT04281459
    Other Study ID Numbers:
    • SCT 4/7
    First Posted:
    Feb 24, 2020
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Azienda Ospedaliera Universitaria Integrata Verona
    Short-cycle therapy
    SCT
    rilpivirine
    HIVTSQs
    patients' satisfaction

    Study Results

    No Results Posted as of Jul 30, 2021