Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients

This is an interventional treatment trial for HIV Infections focused on measuring HIV treatment, Treatment-naive, Adult Read More

Inclusion Criteria:

• Documented HIV-1 infection.
• Treatment naïve (defined as having never received any HIV antiretroviral agents in past).
• CD4+ T-cell count greater than or equal to 50 cells/mm3
• HIV viral load greater than or equal to 5,000 copies/mL

• Laboratory values obtained by screening laboratories within 30 days of entry:

  • Absolute neutrophil count (ANC) greater than 750/mm3.
  • Hemoglobin greater than 8.0 g/dL.
  • Platelet count greater than 50,000/mm3.

  • Calculated creatinine clearance (CrCl) > 60 mL/min as estimated by the Cockcroft-Gault equation:

    • For men, (140 - age in years) x (body weight in kg) ÷ (serum creatinine in mg/dL x 72) = CrCl (mL/min)
    • For women, multiply the result by 0.85 = CrCl (mL/min)
  • AST (SGOT), ALT (SGPT), and alkaline phosphatase less than 5 x ULN.
  • Total bilirubin less than 2.5 x ULN.
• Females of childbearing potential must have a negative serum pregnancy test at screening and agree to use a double-barrier method of contraception throughout the study period.
• Men and women age greater than or equal to 18 years.
• Ability to obtain prescription for HIV antiretroviral medications and to have required prescriptions filled prior to entry.
• Ability and willingness of subject to give written informed consent

Exclusion Criteria:

• Pregnancy or breast-feeding
• Serious illness requiring systemic treatment and/or hospitalization until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry (day 0).
• Acute therapy for serious infection or other serious medical illnesses (in the judgment of the site investigator) requiring systemic treatment and/or hospitalization within 14 days prior to study entry (day 0).
• Evidence of HIV seroconversion within 6 months prior to study entry.
• Evidence of any major HIV drug resistance-associated mutation on any genotype performed prior to study entry or at the time of screening.
• History of chronic hepatitis C (defined as HCV antibody positive and HCV RNA detectable).
• History of chronic active hepatitis B (defined as surface antigen positive and/or HBV DNA detectable).
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Use of any immunomodulator, HIV vaccine, or investigational therapy within 30 days of study entry.
• Use of human growth hormone within 30 days prior to study entry.
• Initiation of testosterone or anabolic steroids within 30 days prior to study entry. (Exception: Chronic replacement dosages in patient's with diagnosed hypogonadism is allowed).