The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Ribavirin; Raltegravir
Intervention description: 800mg once daily; 400mg twice daily
Intervention MeSH terms: Ribavirin; Raltegravir Potassium
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      The purpose of this study is to look at levels of both a new anti-HIV drug called raltegravir
      and an existing anti-hepatitis C drug called ribavirin to see if they affect the blood levels
      of each other when given separately and together. This is a phase I, open-label, prospective,
      three phase, pharmacokinetic study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The ability to understand and sign a written informed consent form, prior to
             participation in any screening procedures and must be willing to comply with all study
             requirements.

          -  Male or non-pregnant, non-lactating female.

          -  Between 18 to 60 years, inclusive.

          -  Subjects in good health upon medical history, physical exam, and laboratory testing
             and body mass index below 32.

          -  Female subjects who are heterosexually active and of childbearing potential (i.e., not
             surgically sterile or at least two years post menopausal) must practice contraception
             as follows from screening through completion of the study including 180 days following
             last dose of study drug:

               -  barrier contraceptives (condom, diaphragm with spermicide)

               -  oral combined contraceptive pill, implant or injectable hormonal contraceptive
                  PLUS a barrier contraceptive

               -  Intrauterine device (IUD) or intrauterine system (IUS) PLUS a barrier
                  contraceptive (or a partner who has been vasectomized for at least six months).

          -  Female subjects of childbearing potential must have a negative urine pregnancy test.

          -  Male subjects who are heterosexually active must use two forms of barrier
             contraception (e.g., condom with spermicide) during heterosexual intercourse, from
             screening through completion of the study including 180 days following last dose of
             study drug.

          -  Have no serologic evidence of HIV infection.

          -  Have no serologic evidence of active hepatitis B virus infection evidenced by negative
             hepatitis B surface antigen and no serologic evidence of hepatitis C virus infection
             through antibody testing.

          -  Have screening laboratory results (haematology, chemistry) that fall within the normal
             range of the central laboratory's reference ranges unless the results have been
             determined by the Investigator to have no clinical significance.

        Exclusion Criteria:

          -  Any serious or active medical or psychiatric illness which, in the opinion of the
             Investigator, would interfere with subject treatment, assessment, or compliance with
             the protocol. This would include any active clinically significant renal, cardiac,
             hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease),
             immunodeficiency disorders, active infection, or malignancy.

          -  Have a body mass index (BMI) greater than 32

          -  Previous participation in an investigational trial involving administration of any
             investigational compound within 1 month prior to the study screening.

          -  Clinically relevant alcohol or drug use (positive screening drug screen) or history of
             alcohol or drug use considered by the Investigator to be sufficient to hinder
             compliance with treatment, follow-up procedures or evaluation of adverse events.
             Smoking is permitted, but tobacco intake should remain consistent throughout the
             study.

          -  Any medication taken listed in Prior and Concomitant Medication section including
             over-the-counter medications and herbal products within 21 days of commencing study
             drug dosing with the exception of vitamins and/or paracetamol and/or hormonal
             contraceptives including the combined oral contraceptive pill, Depo-Provera and the
             Mirena intrauterine system. When a concomitant medication is necessary, this will be
             reviewed by the Investigator and if not contraindicated, may be continued at the same
             dose and frequency during the study period.

          -  History of drug sensitivity or drug allergy.