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.

Phase 4

Completed

Interventions: Drug: atazanavir/raltegravir
Drug: atazanavir/tenofovir/emtricitabine

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

HIV-1 infection
Treatment with a stable antiretroviral regiment containing boosted atazanavir, tenofovir and emtricitabine at screen and for at least 90 days prior to screening
No plan to make changes to HIV treatment regimen (other than those required by the study) in the next 48 weeks
Undetectable HIV RNA at screening AND no HIV RNA>200 copies during the 180 day period prior to screening
CD4 count>200
No evidence of resistance to any of the drugs in any of the 3 arms, if prior resistance tests are available
Subjects who, in the opinion of their treating physicians, would be candidates to switch antiretroviral medications
Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug
Ability and willingness to provide written informed consent and comply with protocol requirements

Exclusion Criteria

Prior exposure to raltegravir or elvitegravir
Women who are pregnant, breast-feeding, or with a positive pregnancy test
Sexually active fertile men not using effective birth control if their female partners are of child-bearing potential
Women of child-bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug
Life expectancy less than 6 months
Presence of any currently active AIDS defining conditions with the exception of stable cutaneous Kaposi's sarcoma
Treatment with proton-pump inhibitor or H2-receptor antagonist
ECG demonstrating atrioventricular block, prolonged QRS interval greater than 12 ms, or known complete bundle branch block
Acute or chronic hepatitis B infection as evidenced by presence of hepatitis B surface antigen and absence of hepatitis B surface antibody
Clinical or laboratory evidence of significantly decreased hepatic function of decompensation irrespective of liver enzyme levels
Prisoners or subjects who are involuntarily incarcerated
Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness

Arm && Interventions

Group	Intervention	Description
Intervention Arm No.1	atazanavir/raltegravir	-
Intervention Arm No.2	atazanavir/raltegravir	-
Control Arm	atazanavir/tenofovir/emtricitabine	Continue baseline regimen

Primary Outcome Measures

Name	Time	Method
Maintenance of Virologic Suppression	48 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life From Baseline to 48 Weeks of Study Treatment	baseline and 48 weeks	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.
The Difference in CD4 From Baseline to Week 48	Baseline and Week 48	Change in mean CD4 from Baseline to Week 48.
The Change in Adherence to Study Treatment Arm From Baseline to Week 48	Baseline and 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.

Locations (9): Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Treasure Coast Infectious Disease Consultants
🇺🇸
Vero Beach, Florida, United States
Christi Research
🇺🇸
Wichita, Kansas, United States
Whitman-Walker Clinic
🇺🇸
Washington, D.C., District of Columbia, United States
David M. Lee, MD, PA d/b/a/ Uptown Physicians' Group
🇺🇸
Dallas, Texas, United States
Denver Public Health
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Denver, Colorado, United States
Orlando Immunology Center
🇺🇸
Orlando, Florida, United States
Community Research Initiative of New England - Boston
🇺🇸
Boston, Massachusetts, United States
AIDS Healthcare Foundation
🇺🇸
Los Angeles, California, United States