A Study to Compare Effectiveness and Safety of Darunavir/Ritonavir (DRV/Rtv) 800mg/100mg Once Daily Versus DRV/Rtv 600mg/100mg Twice Daily in Early Treatment-Experienced HIV-1 Infected Patients (ODIN)
Condition: Human Immunodeficiency Virus - Type 1
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Darunavir (DRV); Ritonavir (rtv)
Intervention description: DRV/rtv 800/100 mg once daily group: 2 tablets of 400 mg of DRV administered orally once daily. DRV/rtv 600/100 mg twice daily group: 1 tablet of 600 mg DRV administered orally twice daily.; DRV/rtv 800/100 mg once daily group: One capsule of 100 mg of ritonavir administered orally once daily. DRV/rtv 600/100 mg twice daily group: One capsule of 100 mg of ritonavir administered orally twice daily.
Intervention MeSH terms: Ritonavir; Darunavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 590.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human immunodeficiency virus - type 1; HIV-1 Infection; TMC-114; Darunavir; Ritonavir

Summary:

      The purpose of this study is to test if being treated with darunavir/ritonavir (DRV/rtv)
      800/100 mg daily is as effective as being treated with DRV/rtv 600/100 mg twice daily, in
      early antiretroviral (ARV)-experienced patients when given along with selected optimized
      background regimen (OBR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with documented human immunodeficiency virus - Type 1 (HIV-1) infection

          -  Patients with a viral load greater than 1,000 HIV-1 ribonucleic acid (RNA) copies/mL

          -  Stable highly active antiretroviral therapy (HAART) regimen for at least 12 weeks at
             screening

          -  In the investigator's opinion, non-nucleoside reverse transcriptase inhibitors
             (NNRTIs) are not a valid treatment option, because of the patient's antiretroviral
             (ARV) treatment history, ARV resistance testing, medication-taking behavior, safety
             and tolerability concerns, or other patient-related factors

          -  Prescreening or/and screening plasma HIV-1 RNA greater than 1,000 copies/mL on HAART
             regimen at screening

        Exclusion Criteria:

          -  Presence of any currently active conditions that fit the definition of the World
             Health Organization (WHO) Clinical Stage 4, with the following exceptions: stable
             cutaneous kaposi's sarcoma (ie, no internal organ involvement other than oral lesions)
             that is unlikely to require any form of systemic therapy during the study time period,
             wasting syndrome

          -  Patients for whom an investigational ARV is part of the current regimen, with the
             following exceptions if applicable (depending on local regulatory approval):
             tenofovir, emtricitabine

          -  Previous or current use of enfuvirtide (ENF), tipranavir and/or DRV

          -  Life expectancy of less than 12 months

          -  Pregnant or breast-feeding females

          -  Any active clinically significant disease (eg, tuberculosis [TB], cardiac dysfunction,
             pancreatitis, acute viral infections) or findings during screening of medical history
             or physical examination that, in the investigator's opinion, would compromise the
             patient's safety or outcome of the study