A Single-arm, Open-label, Study to Assess the Pharmacokinetics of Darunavir and Ritonavir, Darunavir and Cobicistat, Etravirine, and Rilpivirine in HIV-1 Infected Pregnant Women
Condition: HIV; HIV Infections; Pregnancy
MeSH terms: HIV Infections
Intervention: Darunavir; Ritonavir; Etravirine; Rilpivirine; Darunavir/Cobicistat (FDC)
Intervention description: TMC114 (darunavir) two 300 mg or one 600 mg tablet twice daily up to 12 weeks postpartum in Group 1. TMC114 (darunavir) 800mg tablet once daily up to 12 weeks postpartum in Group 2.; 100 mg tablet twice daily up to 12 weeks postpartum.; 200 mg (1*200 mg/2*100 mg) tablets twice daily up to 12 weeks postpartum.; One 25 mg tablet once daily up to 12 weeks postpartum.; Fixed dose combination (FDC) tablet of TMC114 (darunavir) 800 mg and cobicistat 150 mg once daily up to 12 weeks postpartum.
Intervention MeSH terms: Ritonavir; Darunavir; Cobicistat; Rilpivirine; Cobicistat mixture with darunavir; Etravirine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Pregnancy; Postpartum; Human immunodeficiency virus; PREZISTA; INTELENCE; NORVIR; TMC114; TMC125; darunavir; ritonavir; etravirine; rilpivirine; TMC278; Cobicistat; treatment experienced

Summary:

      The purpose of this study is to study how changes in the body during pregnancy influence the
      blood levels of TMC114 (darunavir) and ritonavir taken together, darunavir and cobicistat
      taken as a fixed-dose combination, TMC125 (etravirine) taken alone or with darunavir and
      ritonavir or rilpivirine in patients with human immunodeficiency virus-1 (HIV-1). This study
      will examine how these drugs are absorbed in the body, how they are distributed within the
      body and how they are removed from the body over time. Any pregnant woman who is currently
      receiving darunavir with ritonavir, darunavir with cobicistat, etravirine or rilpivirine for
      HIV-1, and who meets the eligibility criteria for the study, will be allowed to enroll.
      Patients must be willing to remain on study medication during the course of their pregnancy,
      and 12 weeks postpartum. The information collected may help answer questions about how to
      best prescribe these three drugs for pregnant women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant females (18-26 weeks of gestation)

          -  documented HIV-1 infection

          -  Receiving darunavir/ritonavir, darunavir/cobicistat, etravirine, or rilpivirine at the
             time of study entry

          -  Willing to remain on darunavir/ritonavir, darunavir/cobicistat, etravirine, or
             rilpivirine as well as a background regimen, for the duration of the study, including
             12 weeks postpartum

          -  Able to comply with the protocol requirements and to provide written informed consent.

        Exclusion Criteria:

          -  Patients with any currently active acquired immune deficiency syndrome (AIDS) defining
             illness and AIDS-related opportunistic infection

          -  Patients using cytokine inhibitors (e.g., thalidomide), anabolic hormones, cytokines
             (e.g., IL-2, INF), efavirenz, hydroxyurea, oral hypoglycemics, systemic chemotherapy
             or known teratogenic agent

          -  Use of an investigational agent within 90 days

          -  Any known fetal anomaly

          -  Any current obstetric complication, including multiple gestations and pre-term labor

          -  Hepatitis B and/or C virus infection

          -  Grade 2 or higher anemia

          -  Thyroid disease

          -  Uncontrolled Diabetes Mellitus Types I and II, or gestational diabetes, as determined
             by the investigator