Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r)
Condition: Human Immunodeficiency Virus (HIV)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: Darunavir/Ritonavir (DRV/r); Lopinavir in fixed combination with Ritonavir; Zidovudine; NRTIs; Efavirenz
Intervention description: Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use. Tablet is taken once a day, for 28 days; Ritonavir (r) type=exact number, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.; type=exact number, unit=mg, number=400/100, form=tablet, route=oral use. Tablet is taken once or twice a day, for at least 28 days and a maximum of 30 days.; type=exact number, unit=mg, number=250, form=tablet, route=oral use. Tablet is taken twice a day, for at least 28 days and a maximum of 30 days.; The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.; type=exact number, unit=mg, number=600, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir; Zidovudine; Efavirenz
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Human Immunodeficiency Virus (HIV) Post exposure prophylaxis; DRV/r; Occupational injury; Non-occupational exposure; Prezista; Darunavir/r

Summary:

      The primary purpose of this study is to assess the rate of early discontinuation from
      randomized Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) for any reason
      other than confirmation of the negative HIV infection status of the index person in patients
      receiving HIV PEP for at least 28 and a maximum of 30 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Occupational injury and non-occupational exposure with documented human
             immunodeficiency virus (HIV) exposure, or potential for HIV exposure

          -  Indication for HIV postexposure prophylaxis (PEP), as determined by the treating
             physician and/or the investigator

          -  Women must be: postmenopausal (for at least 2 years), surgically sterile, using oral
             contraceptives

          -  Willing to continue HIV PEP for 28 days

        Exclusion Criteria:

          -  Positive HIV rapid test

          -  History of liver or renal insufficiency; significant cardiac, vascular, pulmonary,
             gastro intestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or
             metabolic disturbances

          -  Pregnant or breast-feeding

          -  Any condition that, in the opinion of the investigator, would compromise the
             well-being of the participant or the study or prevent the participant from meeting or
             performing study requirements