There is one clinical trial.
The availability of antiretroviral therapy has led to a reduction in morbidity and mortality in patients with chronic HIV infection. The treatment, however, is not free of side effects, has potential interactions with other medications, is expensive and can be complex, especially in those patients who are very experienced and with mutations that give them resistance to multiple drugs. For this reason, the development of simplification strategies that avoid unnecessary exposure to antiretroviral agents remains of great interest. This is a simplification study, in which the investigators try to evaluate that with less medication the investigator can maintain the same virological control of the disease. This would mean a lower burden of medication for patients, facilitating its administration and reducing the number of unwanted side effects. Specifically, the investigators intend to evaluate the treatment with Darunavir / cobicistat plus Dolutegravir as a simplification strategy, since both drugs are taken once a day, have a powerful antiviral activity, even against antiretroviral resistant viruses, and are among the best tolerated (with fewer side effects). The results reported in some observational studies suggest that two-drug therapy (bitherapy) as a simplification strategy could also be safe and effective, however, as far as the investigators know, there are no data and clinical trials that specifically evaluate darunavir / cobicistat plus dolutegravir as a strategy of simplification.
T66I, 74M, E92Q, T97A, F121Y, E138A/K, G140A/S, Y143R/H/C, S147G, Q148H/K/R, N155H AND R263K) in historical genotyping tests. --- T66I --- --- E92Q --- --- T97A --- --- F121Y --- --- E138A --- --- G140A --- --- Y143R --- --- S147G ---
Description: HIV-1 RNA < 50 copies/mL using a Time to Loss of Virological Response (TLOVR).Measure: Plasma HIV-1 RNA < 50 copies/mL at 48 weeks Time: week 48
Description: Percentage of patients developing ART-associated adverse events leading to treatment discontinuation.Measure: Percentage of patients developing ART-associated adverse events Time: Since baseline to week 48
Description: CD4+ cell count changesMeasure: Changes in CD4+ cell count Time: Since baseline to week 48
Description: Emergence of new mutations in HIV-1 protease and integrase assessed with a genotyping test (attempted on any post Day 1 sample with HIV-1 RNA ≥ 50 copies/mL).Measure: Emergence of new mutations in HIV-1 protease and integrase Time: Baseline and in case of virological failure, defined as ≥ 50 copies/mL in 2 consecutive determinations or a single HIV-1 RNA values > 1000 copies/mL. We can observe a virological failure throughout the study (from baseline to week 48)
Description: HIV-1 RNA< 50 copies/mL at 24 weeks by TLOVRMeasure: Plasma HIV-1 RNA < 50 copies/mL at 24 weeks Time: Week 24
Description: HIV-1 RNA < 50 copies/mL at 24 and 48 weeks using the FDA snapshot analysis (sensitivity analysis).Measure: Plasma HIV-1 RNA < 50 copies/mL at 24 and 48 weeks Time: Week 24 and 48
Description: Description of plasmatic trough levels of DTG and DRV/cobi in the experimental group, and in those participants experiencing virological failure.Measure: DTG and DRV/cobi plasma concentration Time: Week 4
Description: ART pricesMeasure: Cost associated with the antirretroviral treatment of the study Time: Since baseline to week 48
Description: Prices of clinical controls during the studyMeasure: Estimated costs of clinical controls Time: Since baseline to week 48