BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated.
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of the Novel Antiretroviral Combination of Atazanavir and Raltegravir in HIV-1 Infected Subjects With Virologic Suppression on a Standard Regimen of Boosted Atazanavir, Tenofovir and Emtricitabine|
- Maintenance of Virologic Suppression [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]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.
- The Difference in CD4 From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]Change in mean CD4 from Baseline to Week 48.
- The Change in Adherence to Study Treatment Arm From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] [ Designated as safety issue: No ]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.
- Change in Quality of Life From Baseline to 48 Weeks of Study Treatment [ Time Frame: baseline and 48 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2009|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
|Experimental: Intervention Arm No.1||
Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
|Experimental: Intervention Arm No.2||
Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Active Comparator: Control Arm
Continue baseline regimen
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
Other Name: Truvada
|United States, Arizona|
|Spectrum Medical Group|
|Phoenix, Arizona, United States, 85012|
|United States, California|
|AIDS Healthcare Foundation|
|Los Angeles, California, United States, 90028|
|United States, Colorado|
|Denver Public Health|
|Denver, Colorado, United States, 80204|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20009|
|United States, Florida|
|Orlando Immunology Center|
|Orlando, Florida, United States, 32803|
|Treasure Coast Infectious Disease Consultants|
|Vero Beach, Florida, United States, 32960|
|United States, Kansas|
|Wichita, Kansas, United States, 67214|
|United States, Massachusetts|
|Community Research Initiative of New England - Boston|
|Boston, Massachusetts, United States, 02215|
|United States, Texas|
|David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group|
|Dallas, Texas, United States, 75804|
|Principal Investigator:||Calvin J Cohen, MD, MSc||Community Research Initiative|