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.

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”

The purpose of this Phase IV pilot study is to evaluate the safety, tolerability, and satisfaction of a NRTI-sparing regimen for participants fully suppressed on an atazanavir/ritonavir 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.

Intervention(s) in this Clinical Trial

• Drug: atazanavir/raltegravir
  • Atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
• Drug: atazanavir/raltegravir
  • Atazanavir 300mg twice daily plus raltegravir 400mg twice daily
• Drug: atazanavir/tenofovir/emtricitabine
  • Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Intervention Arm No.1
• Experimental: Intervention Arm No.2
• Active Comparator: Control Arm
  • Continue baseline regimen

Primary Measures

• To evaluate and compare maintenance of virological suppression with RAL 400mg 2x daily plus ATV dosed either as ATV/RTV 300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada
  • Time Frame: 48 weeks
    Safety Issue?: No

Secondary Measures

• To evaluate the safety of raltegravir 400mg twice daily in conjunction with atazanavir/ritonavir 300/100mg once daily or atazanavir 300mg twice daily
  • Time Frame: 48 weeks
    Safety Issue?: Yes
• To evaluate the tolerability of raltegravir 400mg twice daily in conjunction with atazanavir/ritonavir 300/100mg once daily or atazanavir 300mg twice daily
  • Time Frame: 48 weeks
    Safety Issue?: No
• To evaluate satisfaction with the treatment regimen in subjects on raltegravir 400mg twice daily in conjunction with atazanavir/ritonavir 300/100mg once daily or atazanavir 300mg twice daily
  • Time Frame: 48 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Community Research Initiative of New England Other

Overall Clinical Trial Officials and Contacts

Calvin J Cohen, MD, MSc Principal Investigator Community Research Initiative  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00931801

Study ID Number: 09-102

ClinicalTrials.gov Identifier: NCT00931801

Health Authority: United States: Food and Drug Administration