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: 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 weeksAllocation: N/A
Single 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 ---