This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose ABC/3TC to fixed dose FTC/TDF in virologically suppressed, HIV-1 infected subjects maintained on a PI/r-containing ARV regimen. Subjects were stratified based on the PI/r (ie, lopinavir/ritonavir \[LPV/r\] versus other boosted PIs) in their regimen, and the presence versus absence of comorbidities at screening (diabetes mellitus or cardiovascular disease such as hypertension, coronary artery disease, hyperlipidemia, history of myocardial infarction, cardiomyopathy, valvular heart disease, congenital heart disease, stroke, peripheral vascular disease, or arrhythmias). Subjects were randomized 1:1 to switch to FTC/TDF+PI/r or to continue on their existing regimen. Subjects received study treatment for 48 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
FTC 200 mg/TDF 300 mg tablet, once a day
ABC 600 mg/3TC 300 mg tablet, once a day
Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) < 200 Copies/mL Through Week 48 Based on Time to Loss of Virologic Response (TLOVR) Algorithm
The percentage of participants with HIV-1 RNA \< 200 copies/mL based on TLOVR algorithm at Week 48 was summarized. Participants were considered nonresponders in the TLOVR analysis if they experienced virologic rebound prior to or at Week 48, discontinued study before Week 48, or added a new antiretroviral (ARV) agent prior to completion of the study. Virologic rebound was defined as 2 consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 200 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 200 copies/mL at Week 48 was summarized. Pure virologic response was the percentage of subjects who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 200 copies/mL or the last HIV-1 RNA value \>= 200 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Percentage of Participants With Pure Virologic Response (PVR) for HIV-1 RNA Cutoff at 50 Copies/mL Through Week 48
The percentage of participants with PVR for HIV-1 RNA cutoff at 50 copies/mL at Week 48 was summarized. Pure virologic response was the proportion of participants who did not have a virologic rebound. Virologic rebound was defined as two consecutive HIV-1 RNA values \>= 50 copies/mL or the last HIV-1 RNA value \>= 50 copies/mL followed by discontinuation from the study.
Time frame: Baseline to 48 weeks
Percentage of Participants With HIV-1 RNA < 200 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 200 copies/mL at Week 48 was summarized.
Time frame: 48 weeks
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Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was summarized.
Time frame: 48 weeks
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Calculated Creatinine Clearance (CLcr) Using Ideal Body Weight by Cockcroft-Gault Method at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Estimated Glomerular Filtration Rate (eGFR) by Modified Diet in Renal Disease (MDRD) at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Fasting Glucose at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Fasting Lipid Parameters at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Ratio of Fasting Total Cholesterol Over High-density Lipoprotein (HDL) Cholesterol at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline C-Reactive Protein at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Fibrinogen at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks
Change From Baseline Interleukin-6 (IL-6), Interleukin-10 (IL-10), and Tumor Necrosis Factor-alpha (TNF-alpha) at Week 48
Change = Week 48 value minus baseline value
Time frame: Baseline to 48 weeks