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.
Name: Switch to DTG + FTC
Name: Patient-centered monitoring
Description: Proportion of patients maintaining HIV-RNA <100 copies/ml throughout 48 weeks
Measure: Efficacy of DTG-based maintenance therapy (< 100 copies/ml) Time: 48 weeksDescription: Direct costs of the two study arms from the health care system perspective at week 48
Measure: Costs of a patient-centered ART monitoring Time: 48 weeksDescription: Proportion of patients maintaining HIV-RNA <50 copies/ml throughout 48 weeks
Measure: Efficacy of DTG-based maintenance therapy (<50 copies/ml) Time: 48 weeksDescription: Proportion of patients with HIV-RNA < 50 cp/ml at week 48
Measure: Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis Time: 48 weeksDescription: defined as the first of the two-confirmed HIV-RNA >100 copies/ml (at least two weeks apart)
Measure: HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR) Time: 48 weeksDescription: from baseline to week 48
Measure: Change in CD4 cell count Time: 48 weeksDescription: from baseline to week 48
Measure: Change in HIV-DNA Time: 48 weeksDescription: from baseline to week 48
Measure: Change in lipidic profile Time: 48 weeksDescription: from baseline to week 48
Measure: Change in glucose profile Time: 48 weeksDescription: from baseline to week 48
Measure: Change in Framingham-calculated cardiovascular risk Time: 48 weeksDescription: from baseline to week 48
Measure: Change in glomerular function rate Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with an adverse event Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with a severe adverse event Time: 48 weeksDescription: throughout week 48
Measure: Proportion of patients with CNS adverse event Time: 48 weeksDescription: at 2 and 6 week
Measure: Proportion of patients new to DTG with CNS symptoms Time: 6 weeksDescription: from baseline to weeks 12 and 48
Measure: PROQOL questionnaire Time: 48 weeksDescription: from baseline to weeks 24 and 48
Measure: Patient's monitoring satisfaction for pts in the patient-centered monitoring arm Time: 48 weeksDescription: at week 48
Measure: Global satisfaction of the monitoring Time: 48 weeksDescription: Monitoring satisfaction throughout 48 weeks
Measure: Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options Time: 48 weeksDescription: at week 48
Measure: Patient's treatment satisfaction at week 48 Time: 48 weeksDescription: ART decided to be used in the post study period
Measure: ARV treatment in the post study Time: 48 weeksDescription: at week 48
Measure: Study satisfaction Time: 48 weeksDescription: at week 48
Measure: Cost-effectiveness of study arms Time: 48 weeksDescription: from baseline to week 48
Measure: Change in patient weight Time: 48 weeksDescription: Patient adherence to treatment throughout 48 weeks of follow-up
Measure: Adherence questions Time: 48 weeksDescription: performed outside trial scheduled throughout 48 weeks
Measure: Number of study-related extra clinical visits Time: 48 weeksAllocation: Randomized
Factorial Assignment
There is one SNP
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. --- M184V ---