SNPMiner Trials by Shray Alag


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Report for Clinical Trial NCT03405194

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open‐Label, Randomized Comparison of Elvitegravir‐Cobicistat‐Tenofovir Alafenamide-Emtricitabine Versus Efavirenz‐Tenofovir Disoproxil Fumarate‐Lamivudine in Patients Starting Antiretroviral Therapy on the Day of HIV Diagnosis

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.

NCT03405194 HIV/AIDS

2 Interventions

Name: Elvitegravir, Cobicistat, TAF, FTC

Description: Started on day of HIV diagnosis
Type: Drug
Group Labels: 1

Elvitegravir-Cobicistat-TAF-FTC

Name: Efavirenz, TDF, and 3TC

Description: Started on day of HIV diagnosis
Type: Drug
Group Labels: 1

EFV-TDF-3TC


Primary Outcomes

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 enrollment

Secondary Outcomes

Description: 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 enrollment

Description: Genotypic resistance to EFV and/or nucleoside reverse transcriptase inhibitors

Measure: Baseline resistance to ART medications

Time: Baseline

Description: Median change in CD4 count over the study period (baseline to 48 weeks)

Measure: Change in CD4 count

Time: 48 weeks after enrollment

Description: Proportion of patients meeting the WHO definition for ART treatment failure over the study period

Measure: Virologic failure

Time: 48 weeks after enrollment

Description: 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 testing

Description: 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 weeks

Description: Mean scores on the Pittsburgh Sleep Quality Index

Measure: Sleep Quality

Time: 4, 12, 24, and 48 weeks after enrollment

Description: Mean scores on the Patient Health Questionnaires (PHQ-9) Questionnaire

Measure: Depression

Time: 4, 12, 24, and 48 weeks after enrollment

Description: Proportion of participants who discontinue any drug in the original ART regimen

Measure: Change in ART drugs

Time: 48 weeks after HIV testing after enrollment

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 K65R

- 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 ---



HPO Nodes