BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: ATV; RTV; Tenofovi-Emtricitabine (TDF/FTC) tablet; LPV
Intervention description: 300mg Oral capsules for 96 weeks; 100mg Oral Capsules for 96 weeks; One tablet with 300 mg - 200 mg once a day for 96 weeks.; 400 mg (3 133mg capsules) BID for 96 weeks
Intervention MeSH terms: Emtricitabine; Atazanavir Sulfate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1057.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; Treatment Naive

Summary:

      The purpose of this study is to evaluate the safety, tolerability and antiviral effects of
      atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV.
      A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by
      participants in both arms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV RNA ≥5000 c/ml

        Exclusion Criteria:

          -  Any antiretroviral therapy within 30 days prior to screening;

          -  Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable
             method to avoid pregnancy for the entire study and for up to 8 weeks after the study;

          -  WOCBP using a prohibited contraceptive method

          -  WOCBP who are pregnant or breastfeeding;

          -  Women with a positive pregnancy test on enrollment or prior to study drug
             administration;

          -  Presence of a newly diagnosed HIV-Related opportunistic infection or any medical
             condition requiring acute therapy at the time of enrollment;

          -  Suspected primary (acute) HIV infection;

          -  Prior antiviral therapy (>30 days of NRTI and/or >7 days of non-nucleoside reverse
             transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within
             30 days prior to screening; some exceptions are allowed for ARV therapy in use for
             Mother-to-child transmission;

          -  Participants with Cushing's syndrome;

          -  Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a
             stable replacement dose of thyroid hormone is acceptable provided the thyroid
             stimulating hormone (TSH) performed within 30 days of screening is within normal drug
             range;

          -  Recent therapy with agents with significant systemic myelosuppressive, neurotoxic,
             pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or
             expected need for such therapy at the time of enrollment; or therapy with methadone or
             ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;

          -  Participants with obstructive liver disease;

          -  Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent
             adequate compliance with study therapy or to increase the risk of developing
             pancreatitis or chemical hepatitis;

          -  Proven or suspected acute hepatitis in the 30 days prior to study entry;

          -  Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30
             days prior to study entry;

          -  Inability to swallow capsules;

          -  Active peripheral neuropathy;

          -  Presence of cardiomyopathy (due to any cause) or any significant cardiovascular
             disease, such as unstable ischemic heart disease;

          -  Known, clinically significant cardiac conduction system disease.

          -  Baseline laboratory values measured within 2 weeks prior to initiating study drugs as
             follows:

               1. calculated creatine clearance <60 mL/min as estimated by the Cockcroft-Gault
                  equation;

               2. total serum lipase ≥ 1.4 times the upper limit of normal;

               3. liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;

               4. total serum bilirubin ≥ 1.5 times the upper limit of normal.

          -  Hypersensitivity to any component of the formulation of study drug;

          -  Prohibited therapies;

          -  Any other clinical conditions or prior therapy that, in the opinion of the
             Investigator, would make the participant unsuitable for study or unable to comply with
             the dosing requirements;

          -  Prisoners or participants 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.