Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Raltegravir; Lopinavir/Ritonavir; Truvada
Intervention description: 1, 400mg tablet twice a day, with Truvada 1 tablet once a day; 2 tablets twice a day, with Truvada 1 tablet once a day; 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Raltegravir; Lopinavir

Summary:

      This program is designed to study the efficacy, safety, lipid effects and tolerability of
      raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not
      received prior antiretroviral therapy. All patients will receive concomitant therapy with
      Truvada.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Documented HIV infection confirmed by western blot or HIV RNA.

          2. At least 18 years of age.

          3. Less than 1 week of prior antiretroviral therapy.

          4. In the opinion of the investigator, patients should be clinically stable. Patients may
             be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.

          5. Patients who are of reproductive potential agree to use an acceptable method of birth
             control throughout the study. Acceptable methods include an intrauterine device (IUD),
             diaphragm with spermicide, condoms, or abstinence.

          6. HIV RNA > 5000 copies/ml. No restriction on CD4 cell count.

          7. A negative urine pregnancy test on the day of initiation of therapy.

        Exclusion Criteria:

          1. Prior treatment with >1week of antiretroviral therapy.

          2. Patient requires or is anticipated to require any of the prohibited medications noted
             in the protocol.

          3. HIV RNA < 5000 prior to receiving therapy.

          4. Baseline resistance to any of the study regimen drugs on genotype testing.

          5. Patients with acute hepatitis due to any cause or clinically significant chronic liver
             disease.

          6. Patient with severe renal insufficiency defined as a calculated creatinine clearance
             at time of screening <30mL/min, based on the Cockcroft-Gault equation which is as
             follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in
             kg)72 x serum creatinine (mg/dL).

          7. Patient has a condition (including but not limited to alcohol or other substance
             abuse) which in the opinion of the investigator would interfere with patient
             compliance or safety.

          8. A female patient who is pregnant, breast-feeding, or expecting to conceive or donate
             eggs during the study; or a male patient who is planning to impregnate or provide
             sperm donation during the study is excluded.

          9. Inability to obtain signed informed consent from a patient age 18 or older.

         10. Patient has significant hypersensitivity or other contraindication to any of the
             components of the study drug.

         11. Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and
             patients who are currently receiving lipid-lowering therapy are excluded.