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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV-1-infection

Intervention / Treatment
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* Other: HIV Treatment Satisfaction Questionnaire status


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCT 4/7<br>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<br>* Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.<br>* Other names: HIV-TSQs;|
| Active Comparator: Control<br>Patients receiving 3-drug antiretroviral therapy containing rilpivirine with standard scheme of 7 days per week of treatment | Other: HIV Treatment Satisfaction Questionnaire status<br>* Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.<br>* Other names: HIV-TSQs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' satisfaction with their treatment: HIVTSQs | The patients satisfaction will be assessed using HIVTSQs | immediately after outpatient visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short-cycle therapy, SCT, rilpivirine, HIVTSQs, patients' satisfaction