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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03160105
Other study ID # CCER 2016-02210
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 19, 2017
Est. completion date May 20, 2019

Study information

Verified date August 2019
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 186
Est. completion date May 20, 2019
Est. primary completion date April 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Informed consent as documented by signature;

2. Documented HIV-1 infection;

3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical doctor of the SHCS network;

4. = 18 years of age;

5. 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.

6. 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:

1. HIV-2 infection;

2. 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;

3. Creatinine clearance < 50ml/min;

4. ASAT or ALAT >2.5x upper limit of the norm;

5. Known hypersensitivity, intolerance or allergy to DTG or FTC;

6. Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses > 1x/week) to current treatment in the last 6 months;

7. Concomitant use of drugs that decrease DTG blood concentrations including carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and rifampicin;

8. Women who are pregnant or breast-feeding;

9. 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;

10. Evidence of acute or chronic hepatitis B virus infection based on results of serology testing.

Study Design


Intervention

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

Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
Calmy Alexandra

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of DTG-based maintenance therapy (< 100 copies/ml) Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks 48 weeks
Primary Costs of a patient-centered ART monitoring Direct costs of the two study arms from the health care system perspective at week 48 48 weeks
Secondary Efficacy of DTG-based maintenance therapy (<50 copies/ml) Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks 48 weeks
Secondary Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis Proportion of patients with HIV-RNA < 50 cp/ml at week 48 48 weeks
Secondary 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) 48 weeks
Secondary Change in CD4 cell count from baseline to week 48 48 weeks
Secondary Change in HIV-DNA from baseline to week 48 48 weeks
Secondary Change in lipidic profile from baseline to week 48 48 weeks
Secondary Change in glucose profile from baseline to week 48 48 weeks
Secondary Change in Framingham-calculated cardiovascular risk from baseline to week 48 48 weeks
Secondary Change in glomerular function rate from baseline to week 48 48 weeks
Secondary Proportion of patients with an adverse event throughout week 48 48 weeks
Secondary Proportion of patients with a severe adverse event throughout week 48 48 weeks
Secondary Proportion of patients with CNS adverse event throughout week 48 48 weeks
Secondary Proportion of patients new to DTG with CNS symptoms at 2 and 6 week 6 weeks
Secondary PROQOL questionnaire from baseline to weeks 12 and 48 48 weeks
Secondary Patient's monitoring satisfaction for pts in the patient-centered monitoring arm from baseline to weeks 24 and 48 48 weeks
Secondary Global satisfaction of the monitoring at week 48 48 weeks
Secondary Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options Monitoring satisfaction throughout 48 weeks 48 weeks
Secondary Patient's treatment satisfaction at week 48 at week 48 48 weeks
Secondary ARV treatment in the post study ART decided to be used in the post study period 48 weeks
Secondary Study satisfaction at week 48 48 weeks
Secondary Cost-effectiveness of study arms at week 48 48 weeks
Secondary Change in patient weight from baseline to week 48 48 weeks
Secondary Adherence questions Patient adherence to treatment throughout 48 weeks of follow-up 48 weeks
Secondary Number of study-related extra clinical visits performed outside trial scheduled throughout 48 weeks 48 weeks
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