Randomized, open-label study comparing Elvitegravir-Cobicistat-Tenofovir Alafenamide-Emtricitabine (Genvoya) vs. Efavirenz-Tenofovir Disoproxil Fumarate-Lamivudine (EFV-TDF-3TC) in patients starting ART on the day of HIV diagnosis.
Name: Elvitegravir, Cobicistat, TAF, FTC
Description: Started on day of HIV diagnosisType: DrugElvitegravir-Cobicistat-TAF-FTC
Name: Efavirenz, TDF, and 3TC
Description: Started on day of HIV diagnosisType: DrugEFV-TDF-3TC
Description: To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Measure: 48-week viral suppression Time: 48 weeks after enrollmentDescription: Proportion of participants who are retained in care with a plasma HIV-1 RNA level <200 copies/ml
Measure: 12-week viral suppression Time: 12 weeks after enrollmentDescription: Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Measure: Baseline resistance to ART medications Time: BaselineDescription: Median change in CD4 count over the study period (baseline to 48 weeks)
Measure: Change in CD4 count Time: 48 weeks after enrollmentDescription: Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Measure: Virologic failure Time: 48 weeks after enrollmentDescription: Proportion of participants with a new Division of AIDS Grade 3 or 4 adverse event or laboratory abnormality that is at least a one-grade increase from baseline
Measure: Adverse events Time: 48 weeks after HIV testingDescription: Proportion of participants with a new Division of AIDS Grade 1 to 4 neurologic or psychiatric disorder that is at least a one-grade increase from baseline
Measure: Neurologic or psychiatric adverse event Time: 48 weeksDescription: Mean scores on the Pittsburgh Sleep Quality Index
Measure: Sleep Quality Time: 4, 12, 24, and 48 weeks after enrollmentDescription: Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Measure: Depression Time: 4, 12, 24, and 48 weeks after enrollmentDescription: Proportion of participants who discontinue any drug in the original ART regimen
Measure: Change in ART drugs Time: 48 weeks after HIV testing after enrollmentAllocation: Randomized
Parallel Assignment
There is one SNP
- Clinical evidence of cirrhosis (ascites or encephalopathy); - Anticipated need for hepatitis C therapy during the study period; - Baseline CrCl <30 mL/minute by the Cockcroft-Gault equation (late exclusion, as creatinine results will not be available at the time of enrollment); - Either the K65R mutation or more than 3 thymidine analogue mutations on baseline resistance testing (late exclusions, after baseline resistance results are available). --- K65R ---