Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
Condition: HIV
Intervention: Atazanavir; Atazanavir/Ritonavir; Tenofovir/Emtricitabine; Lopinavir/ritonavir
Intervention description: Tablets, Oral, 400 mg, once daily, indefinitely; Tablets, Oral, 300/100 mg, once daily, indefinitely; Tablets, Oral, 300/200 mg, once daily, indefinitely; Tablets, Oral, 400/100 mg, twice daily, indefinitely
Intervention MeSH terms: Ritonavir; Lopinavir; Atazanavir Sulfate; Tenofovir; Emtricitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 710.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Treatment experienced

Summary:

      The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected
      subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS
      sponsored clinical trial and to collect long-term safety information on the treated
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must provide written informed consent

          -  Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or
             tenofovir-emtricitabine at time of screening and viral load is

             ≤ 10,000 copies/mL while on therapy

          -  Subjects who are receiving investigational antiretroviral agents through Expanded
             Access Programs will be allowed to participate following discussion and approval by
             the BMS Medical Monitor

          -  ≥ 16 years of age (or minimum age as determined by local regulatory or as legal
             requirements dictate)

          -  Both females of child-bearing potential and males must utilize effective barrier
             contraception to reduce transmission of sexually transmitted diseases, including HIV.
             Other contraception in addition to barrier methods are permitted, however interactions
             between atazanavir and oral contraceptives have not been studied

        Exclusion Criteria:

          -  WOCBP 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 study

          -  WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in
             this study. However, caution is warranted with coadministration of oral
             contraceptives)

          -  Women who are pregnant or breastfeeding

          -  Women with a positive pregnancy test on enrollment or prior to study drug
             administration, with the exception of women rolling over from AI424182, who may still
             have a positive β-HCG test at the time of enrollment

          -  All subjects previously discontinued from an atazanavir study for any reason

          -  Active alcohol or substance abuse sufficient, in the Investigator's opinion, to
             prevent adequate compliance with study therapy or to increase the risk of developing
             pancreatitis or chemical hepatitis

          -  Any other clinical conditions or prior therapy that, in the opinion of the
             investigator, would make the subject unsuitable for study, or unable to comply with
             the dosing requirements

          -  Any of the following laboratory values:

          -  a) Serum creatinine ≥ 1.5 times the upper limit of normal,

          -  b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,

          -  Hypersensitivity to any component of the formulation of study drug

          -  Refer to Section 6.4.1 which details all prohibited therapies

          -  Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
             treatment of either a psychiatric or physical (e.g., infectious disease) illness must
             not be enrolled into this study