The purpose of this randomized, open-label, multicenter, active-controlled Phase 3b study is to evaluate the noninferiority of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) single-tablet regimen (STR; also referred to as fixed-dose regimen or fixed-dose tablet) relative to regimens consisting of a ritonavir-boosted protease inhibitor (PI+RTV) and two nucleoside reverse transcriptase inhibitors (NRTIs) in virologically suppressed, HIV-1 infected subjects. The FTC/RPV/TDF STR could offer an attractive treatment option to patients who wish to simplify dosing by reducing pill burden or to improve the tolerability of their treatment. Participants will be randomized into 2 groups, the FTC/RPV/TDF STR group, in which participants will switch treatment regimens at the start of the study, and the Stay on Baseline Regimen (SBR)/Delayed Switch group, in which participants will remain on their baseline regimen during the first 24 weeks of the study (designed to provide an initial active control), and may switch to the FTC/RPV/TDF STR at the Week 24 visit. After the 48-week study analysis period, participants may continue to receive the FTC/RPV/TDF STR per protocol before switching to a commercially available source.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
482
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 (QD)
Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information.
Ritonavir (RTV) was administered according to prescribing information.
NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.
University of Alabama - Birmingham
Birmingham, Alabama, United States
Spectrum Medical Group
Phoenix, Arizona, United States
Health for Life Clinic, PLLC
Little Rock, Arkansas, United States
AIDS Healthcare Foundation-Research Center
Beverly Hills, California, United States
Pacific Oaks Medical Group
Beverly Hills, California, United States
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. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Week 48
Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24
The mean (SD) change in CD4 count was analyzed from baseline through Week 24.
Time frame: Baseline to Week 24
Change From Baseline in CD4 Count Through Week 48
The mean (SD) change in CD4 count was analyzed from baseline through Week 48. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Change From Baseline in Fasting Total Cholesterol Through Week 24
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in Fasting Total Cholesterol Through Week 48
The mean (SD) change from baseline in fasting total cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in Fasting HDL Cholesterol Through Week 48
The mean (SD) change from baseline in fasting HDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48
The mean (SD) change from baseline in fasting direct LDL cholesterol (mg/dL) through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
Change From Baseline in Fasting Triglycerides Through Week 24
The mean (SD) change from baseline in fasting triglycerides through Week 24 was analyzed.
Time frame: Baseline to Week 24
Change From Baseline in Fasting Triglycerides Through Week 48
The mean (SD) change from baseline in fasting triglycerides through Week 48 was analyzed. By Week 48, participants FTC/RPV/TDF had received 48 weeks of treatment with FTC/RPV/TDF, while those in the SBR/Delayed Switch group had received only 24 weeks of treatment with FTC/RPV/TDF.
Time frame: Baseline to Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Special Immunology
Costa Mesa, California, United States
Kaiser Permanente
Hayward, California, United States
The Living Hope Foundation
Long Beach, California, United States
Peter J. Ruane, MD, Inc.
Los Angeles, California, United States
Kaiser Permanente
Los Angeles, California, United States
...and 101 more locations