Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection (Simpl'HIV) (Simpl'HIV)
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ClinicalTrials.gov Identifier: NCT03160105 |
Recruitment Status :
Completed
First Posted : May 19, 2017
Last Update Posted : August 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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HIV-1-infection Antiretroviral Therapy Maintenance Therapy | Drug: Switch to DTG + FTC Other: Patient-centered monitoring | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 186 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Intervention 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) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial |
Actual Study Start Date : | May 19, 2017 |
Actual Primary Completion Date : | April 18, 2018 |
Actual Study Completion Date : | May 20, 2019 |
Arm | Intervention/treatment |
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No Intervention: Continuing cART + Standard monitoring
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.
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Experimental: Continuing cART + Patient-centered monitoring
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
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Other: Patient-centered monitoring
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 |
Experimental: Switch to DTG+FTC + Standard monitoring
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
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Drug: Switch to DTG + FTC
Switch from standard cART to DTG + FTC dual maintenance therapy. |
Experimental: Switch to DTG+FTC + Patient-centered monitoring
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
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Drug: Switch to DTG + FTC
Switch from standard cART to DTG + FTC dual maintenance therapy. Other: Patient-centered monitoring 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 |
- 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
- Efficacy of DTG-based maintenance therapy (<50 copies/ml) [ Time Frame: 48 weeks ]Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks
- Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis [ Time Frame: 48 weeks ]Proportion of patients with HIV-RNA < 50 cp/ml at week 48
- HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR) [ Time Frame: 48 weeks ]defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)
- Change in CD4 cell count [ Time Frame: 48 weeks ]from baseline to week 48
- Change in HIV-DNA [ Time Frame: 48 weeks ]from baseline to week 48
- Change in lipidic profile [ Time Frame: 48 weeks ]from baseline to week 48
- Change in glucose profile [ Time Frame: 48 weeks ]from baseline to week 48
- Change in Framingham-calculated cardiovascular risk [ Time Frame: 48 weeks ]from baseline to week 48
- Change in glomerular function rate [ Time Frame: 48 weeks ]from baseline to week 48
- Proportion of patients with an adverse event [ Time Frame: 48 weeks ]throughout week 48
- Proportion of patients with a severe adverse event [ Time Frame: 48 weeks ]throughout week 48
- Proportion of patients with CNS adverse event [ Time Frame: 48 weeks ]throughout week 48
- Proportion of patients new to DTG with CNS symptoms [ Time Frame: 6 weeks ]at 2 and 6 week
- PROQOL questionnaire [ Time Frame: 48 weeks ]from baseline to weeks 12 and 48
- Patient's monitoring satisfaction for pts in the patient-centered monitoring arm [ Time Frame: 48 weeks ]from baseline to weeks 24 and 48
- Global satisfaction of the monitoring [ Time Frame: 48 weeks ]at week 48
- Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options [ Time Frame: 48 weeks ]Monitoring satisfaction throughout 48 weeks
- Patient's treatment satisfaction at week 48 [ Time Frame: 48 weeks ]at week 48
- ARV treatment in the post study [ Time Frame: 48 weeks ]ART decided to be used in the post study period
- Study satisfaction [ Time Frame: 48 weeks ]at week 48
- Cost-effectiveness of study arms [ Time Frame: 48 weeks ]at week 48
- Change in patient weight [ Time Frame: 48 weeks ]from baseline to week 48
- Adherence questions [ Time Frame: 48 weeks ]Patient adherence to treatment throughout 48 weeks of follow-up
- Number of study-related extra clinical visits [ Time Frame: 48 weeks ]performed outside trial scheduled throughout 48 weeks

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
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On standard cART at the time of inclusion, i.e.:
- 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.
Exclusion Criteria:
- HIV-2 infection;
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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;
- 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;
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a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is NOT an exclusion criteria.
b. 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03160105
Switzerland | |
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Basel | |
Basel, Switzerland | |
Departement of Infectious Disease, Bern University Hospital | |
Bern, Switzerland | |
Infectious diseases consultation, University Hospitals of Geneva | |
Genève, Switzerland | |
Infectious Diseases Service, Lausanne University Hospital | |
Lausanne, Switzerland | |
Department of Infectious Diseases, Lugano Regional Hospital | |
Lugano, Switzerland | |
Division of Infectious Diseases and Hospital Epidemiology, Kantonspital St.Gallen | |
St. Gallen, Switzerland | |
Department of Infectious Diseases and Hospital Epidemiology, University Hospital of Zurich | |
Zürich, Switzerland |
Responsible Party: | Calmy Alexandra, Professor, University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT03160105 |
Other Study ID Numbers: |
CCER 2016-02210 |
First Posted: | May 19, 2017 Key Record Dates |
Last Update Posted: | August 29, 2019 |
Last Verified: | August 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Infection Communicable Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |