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Integrase Inhibitor

BIKTARVY® for HIV/AIDS

Phase 4
Waitlist Available
Led By Noah Lee, DO
Research Sponsored by Midland Research Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Summary

This study evaluates the efficacy, safety and tolerability of switching from the older, established single tablet regimen of ATRIPLA® (EFV/FTC/TDF) to a new single tablet regimen of BIKTARVY® (BIC/FTC/TAF), in HIV-1 infected adult subjects who are virologically suppressed (HIV-1 RNA<50 copies/mL).

Eligible Conditions
  • HIV/AIDS

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
assess proportion of patients who develop increase in HIV-1 RNA viral load of ≥ 50 copies/mL
Secondary outcome measures
Assess effect on restoration of immune markers by serial measurement of CD4+ cells
Assess patient reported outcomes by two validated patient questionnaires Philadelphia Sleep Quality Index and HIV Symptom Index
assess effect on lipid cardiovascular risk factors by serial measurement of triglycerides and HDL/LDL cholesterol
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: BIKTARVY®Experimental Treatment1 Intervention
initiation of single pill once daily bictegravir/emtricitabine/tenofovir alafenamide from prior efavirenz/emtricitabine/tenofovir DF
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bictegravir
FDA approved

Find a Location

Who is running the clinical trial?

Midland Research Group, Inc.Lead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,086 Previous Clinical Trials
848,330 Total Patients Enrolled
Noah Lee, DOPrincipal InvestigatorMidland Research Group, Inc.
~13 spots leftby Sep 2025
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