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

July 28, 2021 updated by: Azienda Ospedaliera Universitaria Integrata Verona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' satisfaction with their treatment: HIVTSQs
Time Frame: immediately after outpatient visit
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
Time Frame: 48 weeks before enrollment
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
Time Frame: 48 weeks before enrollment
all the CD4+ cells and CD4+/CD8+ determinations in the 48 weeks before enrollment will be registered
48 weeks before enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 21, 2020

First Posted (Actual)

February 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 30, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SCT 4/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

We will consider sharing IPD upon request by other researchers.

IPD Sharing Time Frame

From start of recruitment onwards

IPD Sharing Access Criteria

by email to the main investigator

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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