Conditions: HIV Infections
Keywords: Healthy Volunteers
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 14
Healthy volunteers: yes

Brief 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.

Detailed description:
Phase I (study day 1 - 14):

* 14 healthy volunteers with a documented negative HIV-1 antibody test during screening procedures will be enrolled.
* On day 1, fasted subjects will be administered ribavirin 800 mg without food (witnessed dosing). This will be followed be a 12 hour detailed pharmacokinetic assessment; blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours.
* This will be followed by a wash-out period.
* As steady state pharmacokinetics of ribavirin are not reached for several weeks, single dosing pharmacokinetics will be assessed in this study

Phase II (study days 15 - 19):

* On day 15, subjects will commence raltegravir 400 mg twice daily. Subjects will attend for safety visits and witnessed dosing during this phase.
* Day 19 - after 4 days of dosing when steady state pharmacokinetics has been reached, subjects will attend for a 12 hour detailed pharmacokinetic visit where following witnessed administration of raltegravir 400 mg without food, blood sampling will be drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours post dose for the assessment of raltegravir plasma exposure.

Phase III (study day 20):

• Subjects will be administered raltegravir 400 mg and ribavirin 800 mg without food. This will be followed by a 12 hour detailed pharmacokinetic assessment with blood sampling drawn at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.

Arms:
arm 1: Treatment with Single dose ribavirin (800 mg) administered on day 1 arm 2: Treatment with Raltegravir (400 mg twice daily) administered from days 15-19 arm 3: Treatment with Ribavirin (800 mg) and Raltegravir (400 mg) administered day 20

Interventions: intervention 1: Ribavirin intervention 2: Raltegravir
Intervention descriptions: intervention 1: 800mg once daily intervention 2: 400mg twice daily

Protocol document: