HIV-1-infectionNCT04281459
Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
A study testing HIV Treatment Satisfaction Questionnaire status in people with HIV-1-infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- HIV Treatment Satisfaction Questionnaire status
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUI Verona - UOC Malattie Infettive e Tropicali c/o Policlinico GB Rossi
Verona, 37134
About this study
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.
Read the 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.
- Conditions
- HIV-1-infection
- Being tested
- HIV Treatment Satisfaction Questionnaire status
- Keywords
- Short-cycle therapy, SCT, rilpivirine, HIVTSQs, patients' satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Treatment Satisfaction Questionnaire statusOther
Also called HIV-TSQs
Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.
| Study group | Role | What they receive |
|---|---|---|
| SCT 4/7 | Experimental | Patients receiving 3-drug antiretroviral therapy containing rilpivirine with short cycle scheme of 4 consecutive days on and 3 days off treatment Receives: Other: HIV Treatment Satisfaction Questionnaire status |
| Control | Active comparator | Patients receiving 3-drug antiretroviral therapy containing rilpivirine with standard scheme of 7 days per week of treatment Receives: Other: HIV Treatment Satisfaction Questionnaire status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' satisfaction with their treatment: HIVTSQs
The patients satisfaction will be assessed using HIVTSQs
Measured: immediately after outpatient visit
Secondary outcomes (2)
Virological suppression in the SCT group
all the Viral Load (copies/ml) determinations in the 48 weeks before enrollment will be registered
Measured: 48 weeks before enrollment
CD4+ cells count and CD4+/CD8+ ratio in the SCT group
all the CD4+ cells and CD4+/CD8+ determinations in the 48 weeks before enrollment will be registered
Measured: 48 weeks before enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimiliano Lanzafame, MD, Principal investigator, AOUI Verona - UOC Malattie Infettive e Tropicali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281459
- Sponsor's protocol ID
- SCT 4/7
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will consider sharing IPD upon request by other researchers.
Publications
Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23. doi: 10.1310/hct0801-19.
PubMed 17434845Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.
PubMed 20442758BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.
PubMed 27562743Rudy BJ, Sleasman J, Kapogiannis B, Wilson CM, Bethel J, Serchuck L, Ahmad S, Cunningham CK; Adolescent Trials Network for HIV/AIDS Interventions. Short-cycle therapy in adolescents after continuous therapy with established viral suppression: the impact on viral load suppression. AIDS Res Hum Retroviruses. 2009 Jun;25(6):555-61. doi: 10.1089/aid.2008.0203.
PubMed 19534628Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.
PubMed 25833895de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.
PubMed 29186458Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.
PubMed 16961550Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients (QUATUOR). Identification number: NCT03256422
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Cycle Therapy in ART Regimens Containing Rilpivirine: Assessment of Patients' Satisfaction
- ClinicalTrials.gov ID
- NCT04281459
- Acronym / sponsor ID
- SCT 4/7
- Conditions
- HIV-1-infection
- Keywords
- Short-cycle therapy, SCT, rilpivirine, HIVTSQs, patients' satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCT 4/7 | Experimental | Other: HIV Treatment Satisfaction Questionnaire statusPatients receiving 3-drug antiretroviral therapy containing rilpivirine with short cycle scheme of 4 consecutive days on and 3 days off treatment |
| Control | Active comparator | Other: HIV Treatment Satisfaction Questionnaire statusPatients receiving 3-drug antiretroviral therapy containing rilpivirine with standard scheme of 7 days per week of treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV Treatment Satisfaction Questionnaire statusAlso: HIV-TSQsAdministration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients. | Other | Control, SCT 4/7 |
Primary outcome
Patients' satisfaction with their treatment: HIVTSQs
Time frame: immediately after outpatient visit
The patients satisfaction will be assessed using HIVTSQs
2 secondary outcomes
Virological suppression in the SCT group
Time frame: 48 weeks before enrollment
CD4+ cells count and CD4+/CD8+ ratio in the SCT group
Time frame: 48 weeks before enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Background: PubMed 17434845Cohen CJ, Colson AE, Sheble-Hall AG, McLaughlin KA, Morse GD. Pilot study of a novel short-cycle antiretroviral treatment interruption strategy: 48-week results of the five-days-on, two-days-off (FOTO) study. HIV Clin Trials. 2007 Jan-Feb;8(1):19-23. doi: 10.1310/hct0801-19.
- Background: PubMed 20442758Reynolds SJ, Kityo C, Hallahan CW, Kabuye G, Atwiine D, Mbamanya F, Ssali F, Dewar R, Daucher M, Davey RT Jr, Mugyenyi P, Fauci AS, Quinn TC, Dybul MR. A randomized, controlled, trial of short cycle intermittent compared to continuous antiretroviral therapy for the treatment of HIV infection in Uganda. PLoS One. 2010 Apr 22;5(4):e10307. doi: 10.1371/journal.pone.0010307.
- Background: PubMed 27562743BREATHER (PENTA 16) Trial Group. Weekends-off efavirenz-based antiretroviral therapy in HIV-infected children, adolescents, and young adults (BREATHER): a randomised, open-label, non-inferiority, phase 2/3 trial. Lancet HIV. 2016 Sep;3(9):e421-e430. doi: 10.1016/S2352-3018(16)30054-6. Epub 2016 Jun 20.
- Background: PubMed 19534628Rudy BJ, Sleasman J, Kapogiannis B, Wilson CM, Bethel J, Serchuck L, Ahmad S, Cunningham CK; Adolescent Trials Network for HIV/AIDS Interventions. Short-cycle therapy in adolescents after continuous therapy with established viral suppression: the impact on viral load suppression. AIDS Res Hum Retroviruses. 2009 Jun;25(6):555-61. doi: 10.1089/aid.2008.0203.
- Background: PubMed 25833895Leibowitch J, Mathez D, de Truchis P, Ledu D, Melchior JC, Carcelain G, Izopet J, Perronne C, David JR. Four days a week or less on appropriate anti-HIV drug combinations provided long-term optimal maintenance in 94 patients: the ICCARRE project. FASEB J. 2015 Jun;29(6):2223-34. doi: 10.1096/fj.14-260315. Epub 2015 Apr 1.
- Background: PubMed 29186458de Truchis P, Assoumou L, Landman R, Mathez D, Le Du D, Bellet J, Amat K, Katlama C, Gras G, Bouchaud O, Duracinsky M, Abe E, Alvarez JC, Izopet J, Saillard J, Melchior JC, Leibowitch J, Costagliola D, Girard PM, Perronne C; ANRS 162-4D Study Group. Four-days-a-week antiretroviral maintenance therapy in virologically controlled HIV-1-infected adults: the ANRS 162-4D trial. J Antimicrob Chemother. 2018 Mar 1;73(3):738-747. doi: 10.1093/jac/dkx434.
- Background: PubMed 16961550Woodcock A, Bradley C. Validation of the revised 10-item HIV Treatment Satisfaction Questionnaire status version and new change version. Value Health. 2006 Sep-Oct;9(5):320-33. doi: 10.1111/j.1524-4733.2006.00121.x.
- BackgroundAntiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients (QUATUOR). Identification number: NCT03256422
- Individual participant dataSharing planned: Yes. We will consider sharing IPD upon request by other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimiliano Lanzafame, MD principal investigator
AOUI Verona - UOC Malattie Infettive e Tropicali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV Treatment Satisfaction Questionnaire status in people with HIV-1-infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' satisfaction with their treatment: HIVTSQs (time frame: immediately after outpatient visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04281459, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.