For participants with HIV taking either lopinavir or fosamprenavir who have elevated triglycerides, this trial will study the change in triglycerides after switching protease inhibitors.
This Phase IV trial will look at lipid and virologic responses after a switch to a more lipid-friendly antiretroviral regimen. Participants will be randomized to receive either boosted atazanavir or boosted darunavir given once daily, along with background NRTIs. This 24-week study will require 4 visits after randomization for evaluation, monitoring, and lab studies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Switch to ATV/r at a dose of 300mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
We designed a study to determine if switching virologically suppressed patients on a regimen containing LPV/r or FPV/r to either DRV/r or ATV/r would result in improved TGs while maintaining virological suppression. Switch to DRV/r at a dose 800mg/100mg QD for 24 weeks. Subjects will continue to maintain their background NRTI drugs throughout the screening period and during the entire study.
Spectrum Medical Group
Phoenix, Arizona, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
Orlando Immunology Center
Orlando, Florida, United States
Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
Time frame: baseline, 24 weeks
At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
Time frame: 24 weeks
The Change in Fasting Triglyceride Level From Baseline to Week 24
Time frame: Baseline to week 24
Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Time frame: Week 4, 12 & 24
Difference in CD4 From Baseline to Week 24
Time frame: baseline to Week 24
Total Cholesterol in the Two Study Groups at 24 Weeks
Time frame: Week 24
LDL Cholesterol at Week 24
Time frame: week 24
HDL Cholesterol at Week 24
Time frame: 24 weeks
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Community Research Initiative
Boston, Massachusetts, United States
Community Research Initiative - West
Springfield, Massachusetts, United States
Abbott Northwestern Infectious Disease and Travel Clinic
Minneapolis, Minnesota, United States
AIDS Community Health Center
Rochester, New York, United States
Philadelphia Fight
Philadelphia, Pennsylvania, United States
David M. Lee, M.D., P.A., a/b/a Uptown Physicians Group
Dallas, Texas, United States
Nicholaos C. Bellos, MD, PA
Dallas, Texas, United States
...and 1 more locations