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

Not Applicable

Completed

• Conditions: HIV-1-infection
• Interventions: Other: HIV Treatment Satisfaction Questionnaire status

• Registration Number: NCT04281459
• Lead Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

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.

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-24
• Study Start: 2020-03-01
• Primary Completion: 2020-06-01
• Study Completion: 2020-11-30
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCT 4/7	HIV Treatment Satisfaction Questionnaire status	Patients receiving 3-drug antiretroviral therapy containing rilpivirine with short cycle scheme of 4 consecutive days on and 3 days off treatment
Control	HIV Treatment Satisfaction Questionnaire status	Patients receiving 3-drug antiretroviral therapy containing rilpivirine with standard scheme of 7 days per week of treatment

Primary Outcome Measures

Name	Time	Method
Patients' satisfaction with their treatment: HIVTSQs	immediately after outpatient visit	The patients satisfaction will be assessed using HIVTSQs

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi; 🇮🇹 Verona, Italy