The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a nucleoside analog reverse-transcriptase inhibitors (NRTI)sparing regimen for participants fully suppressed on an atazanavir/ritonavir based highly active antiretroviral therapy (HAART)regimen plus emtricitabine/tenofovir (Truvada). Several pharmacologic factors support this concept including the favorable drug interaction between atazanavir and raltegravir. Participants will be randomized to either continue on their current regimen or one of two study arms (atazanavir 300mg plus ritonavir 100mg daily plus raltegravir 400mg twice daily or atazanavir 300mg twice daily plus raltegravir 400mg twice daily). Participants will be followed for 48 weeks for safety, tolerability, and satisfaction. After baseline, the participants will have six clinic visits for evaluation and labs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Spectrum Medical Group
Phoenix, Arizona, United States
AIDS Healthcare Foundation
Los Angeles, California, United States
Denver Public Health
Denver, Colorado, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
Orlando Immunology Center
Orlando, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
Christi Research
Wichita, Kansas, United States
Community Research Initiative of New England - Boston
Boston, Massachusetts, United States
David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group
Dallas, Texas, United States
Maintenance of Virologic Suppression
To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA \< 40 copies/mL.
Time frame: 48 weeks
The Difference in CD4 From Baseline to Week 48
Change in mean CD4 from Baseline to Week 48.
Time frame: Baseline and Week 48
The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Time frame: Baseline and Week 48
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
Time frame: baseline and 48 weeks
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