A Study to Determine the Antiviral Activity of TMC310911 When Administered With Ritonavir in Treatment-Naive Human Immunodeficiency Virus - Type 1 (HIV-1) Infected Patients
Condition: Human Immunodeficiency Virus Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: TMC310911 75 mg twice daily; TMC310911 150 mg twice daily; TMC310911 300 mg twice daily; TMC310911 300 mg once daily; Ritonavir 100 mg twice daily; Ritonavir 100 mg once daily
Intervention description: TMC310911 75 mg twice daily orally (by mouth) on Days 1 to 14.; TMC310911 150 mg twice daily orally (by mouth) on Days 1 to 14; TMC310911 300 mg twice daily orally (by mouth) on Days 1 to 14; TMC310911 300 mg once daily orally (by mouth) on Days 1 to 14; Ritonavir 100 mg twice daily orally (by mouth) on Days 1 to 14; Ritonavir 100 mg once daily orally (by mouth) on Days 1 to 14
Intervention MeSH terms: Ritonavir; TMC-310911
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Human immunodeficiency virus type 1; HIV-1; HIV-1 treatment-naive; TMC310911; Protease inhibitor; Ritonavir; Antiviral Activity; HIV Infections; Treatment Naive

Summary:

      The purpose of this study is to evaluate the antiviral activity as measured by the change in
      viral load from baseline in the 14 days following initiation of treatment with 4 different
      dose regimens of TMC310911 co-administered with ritonavir.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented human immunodeficiency virus type 1 (HIV-1) infection for at least 6 months
             prior to the screening date

          -  Participant who has not been treated with a therapeutic HIV vaccine within 1 year
             prior to enrolment and has never been treated with an antiretroviral (ARV) medication
             indicated for the treatment of HIV infection or ARVs for treatment of hepatitis
             B-infection with anti-HIV activity

          -  Participant agrees not to start antiretroviral therapy (ART) before the baseline visit

          -  Able to comply with the protocol requirements and have good accessible veins

          -  HIV-1 plasma viral load at screening visit of above 5,000 HIV-1 Ribonucleic acid
             copies/mL

          -  CD4+ cell count above 200 cells/mm3 at screening

        Exclusion Criteria:

          -  HIV-2 infected participants and/or participants with any active or chronic
             hepato-renal disease

          -  Life expectancy of less than 6 months

          -  Documented acute (primary) HIV-1 infection

          -  Pre-existing protease inhibitor (PI) medication resistance

          -  Any currently active Acquired Immunodeficiency Syndrome (AIDS) - defining illness

          -  Any active clinically significant disease or findings during screening or medical
             history or physical examination that in the investigator's opinion, would compromise
             the outcome of the study

          -  Any confirmed grade 3 or 4 toxicity according to the Division of AIDS (DAIDS) grading
             scale at screening