The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA \< 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
Living Hope Clinical Foundation
Long Beach, California, United States
Peter J. Ruane MD Inc
Los Angeles, California, United States
Anthony Mills MD, Inc.
Los Angeles, California, United States
La Playa Medical Group and Clinical Research
San Diego, California, United States
Dupont Circle Physicians Group, P.C.
Washington D.C., District of Columbia, United States
Whitman Walker Clinic
Washington D.C., District of Columbia, United States
Capital Medical Associates, PC
Washington D.C., District of Columbia, United States
The Kinder Medical Group
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Atlanta ID Group
Atlanta, Georgia, United States
...and 8 more locations
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Time frame: Week 12
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Time frame: Week 24
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
Time frame: Week 48
Plasma Concentration of RPV and EFV at Week 1
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
Time frame: Week 1
Plasma Concentration of RPV and EFV at Week 2
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
Time frame: Week 2
Plasma Concentration of RPV and EFV at Week 4
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
Time frame: Week 4
Plasma Concentration of RPV and EFV at Week 6
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
Time frame: Week 6
Plasma Concentration of RPV and EFV at Week 8
The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
Time frame: Week 8
Plasma Concentration of RPV at Week 12
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Time frame: Week 12
Plasma Concentration of EFV at Week 12
The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12
Time frame: Week 12
Plasma Concentration of RPV at Week 24
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
Time frame: Week 24
Plasma Concentration of RPV at Week 36
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
Time frame: Week 36
Plasma Concentration of RPV at Week 48
The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
Time frame: Week 48
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