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.
Condition: HIV
Intervention: atazanavir/raltegravir; atazanavir/raltegravir; atazanavir/tenofovir/emtricitabine
Intervention description: 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
Intervention MeSH terms: Tenofovir; Emtricitabine; Raltegravir Potassium; Atazanavir Sulfate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIDS; HIV; Atazanavir; Raltegravir; Tenofovir; protease inhibitors

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.
    

Eligibility criteria:

        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