The study aims to assess the safety and efficacy of darunavir 800mg plus the co-formulated elvitegravir/cobicistat/tenofovir disoproxil fumarate (DF)/emtricitabine (Stribild) tablet as a simplification strategy for the treatment of HIV infection in HIV-infected subjects who have had previous antiretroviral treatment experience with multiple-drug regimens. We hypothesize that elvitegravir/cobicistat/tenofovir DF/emtricitabine with darunavir will offer a safe and efficacious treatment simplification strategy for HIV positive patients currently receiving multiple-drug regimens to control their HIV infection.
Name: Treatment simplification
Description: Eligible, consenting subjects will start open-label darunavir 800mg plus the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet once daily with food, following the study procedures at the baseline visit. They will be assessed at weeks 2, 12, 24, 36, and 48 after starting the new regimen.Type: DrugTreat Treatment simplification
Description: Proportion of individuals with plasma HIV RNA <200copies/mL at 12 weeks following regimen switch
Measure: Plasma HIV RNA Time: 12 weeksDescription: Proportion of individuals with plasma HIV RNA < 50 copies/mL at weeks 12, 24 and 48 post switch
Measure: plasma HIV RNA Time: weeks 12, 24 and 48Description: Proportion of individuals with plasma HIV RNA < 200 copies/mL at week 24 and 48 post switch
Measure: plasma HIV RNA Time: week 24 and 48Description: Change in CD4 cell count, CD4% and CD4/CD8 ratio from study baseline to 12, 24 and 48 weeks after switch.
Measure: CD4 cell count, CD4% and CD4/CD8 ratio Time: 12, 24 and 48 weeksDescription: Change in serum creatinine and eGFR from baseline to 12, 24 weeks and 48 weeks.
Measure: serum creatinine and estimated glomerular filtration rate (eGFR) Time: 12, 24, and 48 weeksDescription: Proportion of adverse events experienced necessitating switch to original regimen
Measure: Adverse event discontinuations Time: 48 weeksDescription: Changes in fasting lipid parameters (total cholesterol, LDL, HDL, triglycerides, and apolipoprotein B [apoB]), AST to platelet ratio index (APRI) score, and high-sensitivity C-reactive protein (hsCRP) between baseline and 24 and 48 weeks.
Measure: fasting lipid parameters (total cholesterol, LDL, HDL, triglycerides, and apolipoprotein B [apoB]), AST to platelet ratio index (APRI) score, and high-sensitivity C-reactive protein (hsCRP) Time: 24 and 48 weeksDescription: Change in darunavir trough concentration from baseline to week 2 for individuals receiving darunavir at baseline
Measure: Darunavir plasma concentration Time: week 2Description: Changes in HIV Treatment Satisfaction Questionnaire (HIVTSQ) scores and quality of life indicators (MOS-HIV scores) between baseline and weeks 24 and 48 following switch.
Measure: HIV Treatment Satisfaction Questionnaire (HIVTSQ) scores and quality of life indicators (MOS-HIV scores) Time: weeks 24 and 48Description: Changes in antiretroviral adherence from baseline to 24 and 48 weeks. Adherence will be assessed using two measures: the ACTG treatment adherence questionnaire and the Medication adherence self-report inventory (MASRI).
Measure: Adherence Time: 24 and 48 weeksDescription: Elvitegravir concentrations will be measured at day 14
Measure: Elvitegravir plasma concentrations Time: Day 14Description: Adverse events necessitating a resumption of the previous antiretroviral regimen, and all serious adverse events will be recorded.
Measure: Adverse events Time: 48 weeksSingle Group Assignment
There is one SNP
- Evidence of clinically significant resistance to tenofovir on any previous genotype tests: K65R mutation, or 3 or more thymidine-analogue associated mutations (TAMS) compromising tenofovir activity - Evidence of resistance mutations significantly compromising darunavir activity on any previous genotypic tests - Current use of any nonnucleoside reverse transcriptase inhibitor (NNRTI) - Pregnancy or breast-feeding - Contraindications to tenofovir/FTC, elvitegravir, or cobicistat (e.g. --- K65R ---