The Raltegravir and Ribavirin Pharmacokinetics (PK) Study

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imperial College London
• Treatments: Raltegravir Potassium; Ribavirin

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.