Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-03-02 @ 10:21 AM
Study NCT ID:
NCT04281459
Status:
COMPLETED
Last Update Posted:
2021-07-30
First Post:
2020-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Organization:
Study Overview
Official Title:
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: