A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™
Condition: Infection, Human Immunodeficiency Virus I
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined
      Formulated Tablet compared with maraviroc and Combivir administered concurrently versus
      maraviroc + Combivir. 42 subjects will be enrolled in the study such that 40 subjects
      complete dosing and critical assessments. The total duration of a subject's participation
      will be approximately 33 to 35 days, including a screening period (Day -21 to Day -1), 2
      treatment periods (Days 1-3), at least a 7-day washout between Period 1 and Period 2, and a
      follow-up visit 7 to 14 days after the last dose of study drug in Period 2. Each dosing
      period will begin the evening prior to dosing and extend until 48 hours (Day 3) after dosing.
      Subjects will be randomly assigned to receive 1 of the following 2 treatments in Period 1
      then crossover to receive the alternate treatment in Period 2:

      In Sequence 1 (N=21) subjects will receive Treatment A followed by a 7 day washout and
      Treatment B. In Sequence 2 (N=21) subjects will receive Treatment B followed by a 7 day
      washout and Treatment A. Treatment A consists of 1 tablet of maraviroc 300 mg, lamivudine 150
      mg, and zidovudine 300 mg as a combined formulation after an overnight fast. Treatment B
      consists of 1 tablet of maraviroc 300 mg + 1 tablet of Combivir taken concurrently after an
      overnight fast. On Day 1 of each treatment period, subjects will receive study drug in the
      morning after an overnight fast of at least 8 hours. Study drug will be administered with 240
      mL of water. Dosing in each treatment period will be separated by a minimum washout period of
      at least 7 days between doses. All subjects will undergo safety and other assessments.
      Subjects may be discharged after all study procedures are completed on the morning of Day 3,
      with instructions to return for the next study period or the follow-up visit, as appropriate.
      The follow-up visit will occur 7 to 14 days after the last dose of study drug in Period 2.
      Pharmacokinetic blood samples will be collected during each treatment period for evaluation
      of maraviroc, lamivudine, and zidovudine before dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3,
      4, 6, 8, 12, 18, 24, 36, and 48 hours after dosing (total of 16 PK time points per treatment
      period). Protocol waivers or exemptions are not allowed, with the exception of immediate
      safety concerns. Therefore, adherence to the study protocol requirements, including those
      specified in the Time and Events Table, are essential and required for study conduct.
    


Intervention name(s): Maraviroc; Combivir; GSK2838510
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg; 1 tablet: lamivudine 150mg, zidovudine 300mg; Maraviroc 300mg, lamivudine 150mg, zidovudine 300mg
Intervention MeSH terms: Maraviroc; Lamivudine, zidovudine drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Combivir™, HIV, bioequivalence, Combined Formulated Tablet, Combined Formulated Tablet, HIV, bioequivalence, Combivir, Selzentry™, Celsentri™, lamivudine, zidov