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.
Patients with WHO Stage 1 or 2 disease at HIV diagnosis will be randomized in a 1:1 ratio to either the Genvoya group or the EFV-TDF-3TC group. ART will be initiated on the day of HIV diagnosis. Participants who are found to have a contraindication to their assigned treatment regimen will change ART, and be classified as a failure for their assigned treatment arm. Participants in the EFV-TDF-3TC group with CrCl of 30-50 mL/minute, or with baseline mutations that significantly reduce the susceptibility of EFV will switch to Genvoya. Participants in the Genvoya group who are diagnosed with TB after enrollment will be switched to an ART regimen that can be administered with rifampin. If the study physician determines that a treatment change is indicated due to intolerability or side effects, the relevant clinical data will be presented to a safety committee that is blinded to group assignment. The ART regimen will be changed if the safety committee determines that it is indicated, and the participant will be considered a failure to their assigned treatment group. Patients will be followed for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Started on day of HIV diagnosis
Started on day of HIV diagnosis
48-week viral suppression
To compare the proportion of participants who are retained in care with a plasma HIV-1 RNA level \<200 copies/ml
Time frame: 48 weeks after enrollment
12-week viral suppression
Proportion of participants who are retained in care with a plasma HIV-1 RNA level \<200 copies/ml
Time frame: 12 weeks after enrollment
Baseline resistance to ART medications
Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors
Time frame: Baseline
Change in CD4 count
Median change in CD4 count over the study period (baseline to 48 weeks)
Time frame: 48 weeks after enrollment
Virologic failure
Proportion of patients meeting the WHO definition for ART treatment failure over the study period
Time frame: 48 weeks after enrollment
Adverse events
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
Time frame: 48 weeks after HIV testing
Neurologic or psychiatric adverse event
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
Time frame: 48 weeks
Sleep Quality
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Mean scores on the Pittsburgh Sleep Quality Index
Time frame: 4, 12, 24, and 48 weeks after enrollment
Depression
Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire
Time frame: 4, 12, 24, and 48 weeks after enrollment
Change in ART drugs
Proportion of participants who discontinue any drug in the original ART regimen
Time frame: 48 weeks after HIV testing after enrollment