HIV-1-infectionPhase 4Simpl'HIVNCT03160105
Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV)
A Phase 4 study testing Switch to DTG + FTC and Patient-centered monitoring in people with HIV-1-infection and Antiretroviral Therapy, run by Calmy Alexandra at 7 sites in Switzerland.
Trial summary
The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection, Antiretroviral Therapy, Maintenance Therapy
- What is being tested?
- Switch to DTG + FTC and Patient-centered monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 7 sitesSwitzerland
- Study dates
- 19 May 2017to 20 May 2019
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent as documented by signature;
- Documented HIV-1 infection;
- Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;
- ≥ 18 years of age;
- HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on effective suppressive cART, one blip with less than 200 copies/mL being allowed during this period if followed by at least 2 results < 50 copies/mL.
- On standard cART at the time of inclusion, i.e.:
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- 2 NRTIs + either 1 NNRTI, 1 boosted PI or 1 INSTI;
- NRTI-sparing triple ARV regimen (e.g. 1 NRTI + 1 NNRTI + 1 InSTI);
- Dual therapy with protease inhibitor.
Who cannot join
- HIV-2 infection;
- Previous ART change for unsatisfactory virological response, i.e. slow initial virological suppression, incomplete suppression or rebound. Change of drug or drug class for convenience or toxic effect prevention or management is allowed.
- Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible;
- Creatinine clearance < 50ml/min;
- ASAT or ALAT >2.5x upper limit of the norm;
- Known hypersensitivity, intolerance or allergy to DTG or FTC;
Show all 13Show fewer
- Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses > 1x/week) to current treatment in the last 6 months;
- Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin;
- Women who are pregnant or breast-feeding;
- a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is NOT an exclusion criteria.
- Non availability of previous routine resistance test, at least for reverse transcriptase and protease genes.
- Note: Subjects remain eligible in the absence of any previous resistance test only if they are on their first-line antiretroviral regimen;
- Evidence of acute or chronic hepatitis B virus infection based on results of serology testing.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Switzerland7 sites
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel
Basel
Departement of Infectious Disease, Bern University Hospital
Bern
Infectious diseases consultation, University Hospitals of Geneva
Geneva
Infectious Diseases Service, Lausanne University Hospital
Lausanne
Department of Infectious Diseases, Lugano Regional Hospital
Lugano
Division of Infectious Diseases and Hospital Epidemiology, Kantonspital St.Gallen
Sankt Gallen
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich
Zurich
About this study
Official title: Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial
The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.
Read the detailed description
This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization to switching to DTG-based maintenance dual therapy in association with FTC or continuation of cART, and to patient-centered monitoring or continuation of standard monitoring.
Patients will be followed during 48 weeks.
- Conditions
- HIV-1-infection, Antiretroviral Therapy, Maintenance Therapy
- Being tested
- Switch to DTG + FTC, Patient-centered monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch to DTG + FTCDrug
Switch from standard cART to DTG + FTC dual maintenance therapy.
Patient-centered monitoringOther
Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36
| Study group | Role | What they receive |
|---|---|---|
| Continuing cART + Standard monitoring | No intervention | Patients randomized to this arm will continue their current standard ART regimen (cART) and will continue a standard 3-monthly routine safety biological monitoring (including CD4 cell count, fasting lipids and glucose, renal and hepatic function tests) at their SHCS site. |
| Continuing cART + Patient-centered monitoring | Experimental | Patients randomized to this arm will continue their current cART and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36 Receives: Other: Patient-centered monitoring |
| Switch to DTG+FTC + Standard monitoring | Experimental | Patients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36 Receives: Drug: Switch to DTG + FTC |
| Switch to DTG+FTC + Patient-centered monitoring | Experimental | Patients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed at screening and at week 48. In addition, patients will be ask to choose at least one of the following alternative options for weeks 6, 12 and 36: decentralised venipuncture and blood tests, delivery of ARV drugs by mail and Assessment and clinical interview by phone or skype call Receives: Drug: Switch to DTG + FTC; Other: Patient-centered monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DTG-based maintenance therapy (< 100 copies/ml)
Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks
Measured: 48 weeks
Costs of a patient-centered ART monitoring
Direct costs of the two study arms from the health care system perspective at week 48
Measured: 48 weeks
Secondary outcomes (24)
Efficacy of DTG-based maintenance therapy (<50 copies/ml)
Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks
Measured: 48 weeks
Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis
Proportion of patients with HIV-RNA < 50 cp/ml at week 48
Measured: 48 weeks
HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR)
defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)
Measured: 48 weeks
Change in CD4 cell count
from baseline to week 48
Measured: 48 weeks
Change in HIV-DNA
from baseline to week 48
Measured: 48 weeks
Change in lipidic profile
from baseline to week 48
Measured: 48 weeks
Change in glucose profile
from baseline to week 48
Measured: 48 weeks
Change in Framingham-calculated cardiovascular risk
from baseline to week 48
Measured: 48 weeks
Change in glomerular function rate
from baseline to week 48
Measured: 48 weeks
Proportion of patients with an adverse event
throughout week 48
Measured: 48 weeks
Proportion of patients with a severe adverse event
throughout week 48
Measured: 48 weeks
Proportion of patients with CNS adverse event
throughout week 48
Measured: 48 weeks
Proportion of patients new to DTG with CNS symptoms
at 2 and 6 week
Measured: 6 weeks
PROQOL questionnaire
from baseline to weeks 12 and 48
Measured: 48 weeks
Patient's monitoring satisfaction for pts in the patient-centered monitoring arm
from baseline to weeks 24 and 48
Measured: 48 weeks
Global satisfaction of the monitoring
at week 48
Measured: 48 weeks
Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options
Monitoring satisfaction throughout 48 weeks
Measured: 48 weeks
Patient's treatment satisfaction at week 48
at week 48
Measured: 48 weeks
ARV treatment in the post study
ART decided to be used in the post study period
Measured: 48 weeks
Study satisfaction
at week 48
Measured: 48 weeks
Cost-effectiveness of study arms
at week 48
Measured: 48 weeks
Change in patient weight
from baseline to week 48
Measured: 48 weeks
Adherence questions
Patient adherence to treatment throughout 48 weeks of follow-up
Measured: 48 weeks
Number of study-related extra clinical visits
performed outside trial scheduled throughout 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start19 May 2017
- Primary completion18 Apr 2018
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization. A sample size of 92 patients in each group will be required to demonstrate non-inferiority with a non-inferiority (NI) margin of 12%.
- Masking
- None (open label)
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calmy Alexandra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Calmy Alexandra, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160105
- Sponsor's protocol ID
- CCER 2016-02210
- Acronym
- Simpl'HIV
- Status last verified
- Aug 2019
- First submitted
- 16 May 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marinosci A, Sculier D, Wandeler G, Yerly S, Stoeckle M, Bernasconi E, Braun DL, Vernazza P, Cavassini M, Buzzi M, Metzner KJ, Decosterd L, Gunthard HF, Schmid P, Limacher A, Branca M, Calmy A. Costs and acceptability of simplified monitoring in HIV-suppressed patients switching to dual therapy: the SIMPL'HIV open-label, factorial randomised controlled trial. Swiss Med Wkly. 2024 Apr 15;154:3762. doi: 10.57187/s.3762.
PubMed 38754068Sculier D, Wandeler G, Yerly S, Marinosci A, Stoeckle M, Bernasconi E, Braun DL, Vernazza P, Cavassini M, Buzzi M, Metzner KJ, Decosterd LA, Gunthard HF, Schmid P, Limacher A, Egger M, Calmy A; Swiss HIV Cohort Study (SHCS). Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial. PLoS Med. 2020 Nov 10;17(11):e1003421. doi: 10.1371/journal.pmed.1003421. eCollection 2020 Nov.
PubMed 33170863
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT03160105
- Acronym / sponsor ID
- Simpl'HIV / CCER 2016-02210
- Conditions
- HIV-1-infection, Antiretroviral Therapy, Maintenance Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Calmy AlexandraUniversity, hospital or other
- Study start
- 19 May 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 19 May 2017 (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.
The purpose of this study is to evaluate whether maintenance antiretroviral therapy could be simplified to DTG + FTC dual therapy and/or patient-centered monitoring once virological suppression is achieved. Using a factorial design, the study aims to assess the efficacy of DTG + FTC dual therapy to maintain virological suppression through 48 weeks of follow-up as well as the costs of a patient-centered ART laboratory monitoring.
Detailed description
This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization to switching to DTG-based maintenance dual therapy in association with FTC or continuation of cART, and to patient-centered monitoring or continuation of standard monitoring.
Patients will be followed during 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a pragmatic multicentre, 2x2 factorial randomized controlled trial with 1:1:1:1 randomization. A sample size of 92 patients in each group will be required to demonstrate non-inferiority with a non-inferiority (NI) margin of 12%.
| Arm | Type | Receives |
|---|---|---|
| Continuing cART + Standard monitoring | No intervention | –Patients randomized to this arm will continue their current standard ART regimen (cART) and will continue a standard 3-monthly routine safety biological monitoring (including CD4 cell count, fasting lipids and glucose, renal and hepatic function tests) at their SHCS site. |
| Continuing cART + Patient-centered monitoring | Experimental | Other: Patient-centered monitoringPatients randomized to this arm will continue their current cART and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36 |
| Switch to DTG+FTC + Standard monitoring | Experimental | Drug: Switch to DTG + FTCPatients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed once per year and at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36 |
| Switch to DTG+FTC + Patient-centered monitoring | Experimental | Drug: Switch to DTG + FTC, Other: Patient-centered monitoringPatients randomized to this arm will be switched to DTG + FTC dual maintenance therapy and will have immunological and safety blood examinations performed at screening and at week 48. In addition, patients will be ask to choose at least one of the following alternative options for weeks 6, 12 and 36: decentralised venipuncture and blood tests, delivery of ARV drugs by mail and Assessment and clinical interview by phone or skype call |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent as documented by signature;
- Documented HIV-1 infection;
- Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;
- ≥ 18 years of age;
- HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on effective suppressive cART, one blip with less than 200 copies/mL being allowed during this period if followed by at least 2 results < 50 copies/mL.
Key exclusion criteria (13 listed)
- HIV-2 infection;
- Previous ART change for unsatisfactory virological response, i.e. slow initial virological suppression, incomplete suppression or rebound. Change of drug or drug class for convenience or toxic effect prevention or management is allowed.
- Note: patients with documented genotype(s) presenting only a M184V mutation remain eligible;
- Creatinine clearance < 50ml/min;
- ASAT or ALAT >2.5x upper limit of the norm;
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 |
|---|---|---|
| Switch to DTG + FTCSwitch from standard cART to DTG + FTC dual maintenance therapy. | Drug | Switch to DTG+FTC + Patient-centered monitoring, Switch to DTG+FTC + Standard monitoring |
| Patient-centered monitoringImmunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36 | Other | Continuing cART + Patient-centered monitoring, Switch to DTG+FTC + Patient-centered monitoring |
Primary outcome
Efficacy of DTG-based maintenance therapy (< 100 copies/ml)
Time frame: 48 weeks
Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks
Costs of a patient-centered ART monitoring
Time frame: 48 weeks
Direct costs of the two study arms from the health care system perspective at week 48
24 secondary outcomes
Efficacy of DTG-based maintenance therapy (<50 copies/ml)
Time frame: 48 weeks
Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis
Time frame: 48 weeks
HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR)
Time frame: 48 weeks
Change in CD4 cell count
Time frame: 48 weeks
Change in HIV-DNA
Time frame: 48 weeks
Change in lipidic profile
Time frame: 48 weeks
Change in glucose profile
Time frame: 48 weeks
Change in Framingham-calculated cardiovascular risk
Time frame: 48 weeks
Change in glomerular function rate
Time frame: 48 weeks
Proportion of patients with an adverse event
Time frame: 48 weeks
Proportion of patients with a severe adverse event
Time frame: 48 weeks
Proportion of patients with CNS adverse event
Time frame: 48 weeks
Proportion of patients new to DTG with CNS symptoms
Time frame: 6 weeks
PROQOL questionnaire
Time frame: 48 weeks
Patient's monitoring satisfaction for pts in the patient-centered monitoring arm
Time frame: 48 weeks
Global satisfaction of the monitoring
Time frame: 48 weeks
Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options
Time frame: 48 weeks
Patient's treatment satisfaction at week 48
Time frame: 48 weeks
ARV treatment in the post study
Time frame: 48 weeks
Study satisfaction
Time frame: 48 weeks
Cost-effectiveness of study arms
Time frame: 48 weeks
Change in patient weight
Time frame: 48 weeks
Adherence questions
Time frame: 48 weeks
Number of study-related extra clinical visits
Time frame: 48 weeks
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 29 Aug 2019.
- Derived from this study: PubMed 38754068Marinosci A, Sculier D, Wandeler G, Yerly S, Stoeckle M, Bernasconi E, Braun DL, Vernazza P, Cavassini M, Buzzi M, Metzner KJ, Decosterd L, Gunthard HF, Schmid P, Limacher A, Branca M, Calmy A. Costs and acceptability of simplified monitoring in HIV-suppressed patients switching to dual therapy: the SIMPL'HIV open-label, factorial randomised controlled trial. Swiss Med Wkly. 2024 Apr 15;154:3762. doi: 10.57187/s.3762.
- Derived from this study: PubMed 33170863Sculier D, Wandeler G, Yerly S, Marinosci A, Stoeckle M, Bernasconi E, Braun DL, Vernazza P, Cavassini M, Buzzi M, Metzner KJ, Decosterd LA, Gunthard HF, Schmid P, Limacher A, Egger M, Calmy A; Swiss HIV Cohort Study (SHCS). Efficacy and safety of dolutegravir plus emtricitabine versus standard ART for the maintenance of HIV-1 suppression: 48-week results of the factorial, randomized, non-inferiority SIMPL'HIV trial. PLoS Med. 2020 Nov 10;17(11):e1003421. doi: 10.1371/journal.pmed.1003421. eCollection 2020 Nov.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Switch to DTG + FTC and Patient-centered monitoring in people with HIV-1-infection and Antiretroviral Therapy, run by Calmy Alexandra at 7 sites in Switzerland.
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 9 inclusion and 13 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 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of DTG-based maintenance therapy (< 100 copies/ml) (time frame: 48 weeks). The study lists 2 primary outcomes in all. 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 NCT03160105, which also lists 2 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 29 Aug 2019.