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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2020-11-30

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.

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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.

Conditions

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HIV-1-infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

HIV Treatment Satisfaction Questionnaire status

Intervention Type OTHER

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

Control

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

Group Type ACTIVE_COMPARATOR

HIV Treatment Satisfaction Questionnaire status

Intervention Type OTHER

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

Interventions

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HIV Treatment Satisfaction Questionnaire status

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

Intervention Type OTHER

Other Intervention Names

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HIV-TSQs

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No