Study Comparing Lopinavir/Ritonavir (LPV/r) + Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) With a Nucleoside Sparing Regimen Consisting of Lopinavir/Ritonavir + Raltegravir (RAL)
Condition: Human Immunodeficiency Virus Infection
MeSH terms: Virus Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: lopinavir/ritonavir (LPV/r); emtricitabine/tenofovir disoproxil fumarate (FTC/TDF); raltegravir (RAL)
Intervention description: LPV/r 400/100 mg BID; FTC/TDF 200/300 mg QD; RAL 400 mg BID
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Emtricitabine; Raltegravir Potassium; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus infection

Summary:

      The purpose of this study is to compare the safety, tolerability, and antiviral activity of
      the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase
      inhibitors to lopinavir/ritonavir tablets when administered in combination with a human
      immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1
      infected subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must provide written, voluntary informed consent to participate in the
             study.

          -  Participants must be naive to antiretroviral treatment with HIV RNA greater than or
             equal to 1,000 copies/mL at screening, and in the investigator's opinion, require
             antiretroviral therapy.

          -  Participant's vital signs, physical examination, and laboratory results must not
             exhibit evidence of acute illness.

          -  Participant has not been treated for an active acquired immune deficiency syndrome
             (AIDS)-defining opportunistic infection within 45 days of initiating study drug.
             Participants who are on stable maintenance therapy for an opportunistic infection may
             be enrolled after consultation with the Sponsor.

          -  Participant does not require and agrees not to take any drugs that are contraindicated
             or have significant pharmacokinetic interactions with study drugs during the course of
             the study. Participant agrees not to take any medication during the study, including
             over-the-counter medicines, vitamins, minerals, herbal preparations, alcohol, or
             recreational drugs without the knowledge and permission of the principal investigator.

          -  Female participants must be either postmenopausal for at least one year, surgically
             sterile, or must use a non-hormonal method of birth control that is acceptable to both
             the participant and investigator. All female participants must have a urine pregnancy
             test performed at screening visit and on Day minus 1/baseline, and results of both
             tests must be negative. Female participants may not be breastfeeding.

          -  Participants have received no prior treatment with an HIV-1 integrase inhibitor.

        Exclusion Criteria:

          -  Participants must not have history of an allergic reaction or significant sensitivity
             to the study drugs.

          -  Participants may not have an ongoing history of substance abuse or psychiatric illness
             that could preclude protocol adherence.

          -  Participant cannot have resistance to lopinavir/ritonavir, tenofovir, or emtricitabine
             based on the HIV-1 drug resistance genotypic test results at the screening visit.

          -  Participant may not have significant medical history of concomitant illness or disease
             that would adversely affect his/her participating in the study.

          -  Participants may not have received any investigational drug or investigational vaccine
             within 30 days prior to study drug administration.

          -  Participants may not have any of the following abnormal screening results: Hemoglobin
             <= 8.0 grams/deciliter, absolute neutrophil count <= 750 cells/microliter, Platelet
             count <= 50,000 per milliliter, alanine aminotransferase (ALT) (serum glutamic-pyruvic
             transaminase [SGPT]) or aspartate aminotransferase (AST) (serum glutamic oxaloacetic
             transaminase [SGOT]) >= 3.0 x upper limit of normal (ULN), calculated creatinine
             clearance < 50 milliliter/minute, hepatitis B surface antigen (HBsAg) is positive.

          -  The investigator considers the participant to be an unsuitable candidate for the
             study.