Status:
COMPLETED
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
Lead Sponsor:
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-65 years
Phase:
NA
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 receivin...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04281459
Start Date
March 1 2020
End Date
November 30 2020
Last Update
July 30 2021
Active Locations (1)
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1
AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi
Verona, Italy, 37134