The Raltegravir and Ribavirin Pharmacokinetics (PK) Study
|ClinicalTrials.gov Identifier: NCT00982553|
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : June 13, 2011
Last Update Posted : November 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Ribavirin Drug: Raltegravir||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-label, Three Phase Pharmacokinetic Study, to Assess the Pharmacokinetic Profile and Safety of Raltegravir 400 mg Twice Daily and Ribavirin 800 mg Once Daily, When Dosed Separately and Together in Healthy Volunteers|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||December 2009|
Ribavirin then Raltegravir + Ribavirin
800mg once daily
Other Name: Copegus
400mg twice daily
- Ribavirin Alone Maximum Plasma Concentration [ Time Frame: Day 1 ]On day 1 participants were administered a single dose of Ribavirin 800mg and then intensive pharmacokinetic blood samples were collected at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 12 hours
- Raltegravir Alone Maximum Plasma Concentration [ Time Frame: Day 19 ]After a 14 day wash out participants took raltegravir 400 mg twice daily for 4 days. on day 19 they attended for intensive pharmacokinetic tests at 0 (pre-dose of raltegravir 400mg)then 0.5, 1, 2, 3, 4, 6, 8 and 12 hours
- Ribavirin Maximum Plasma Concentration When Co-administered [ Time Frame: Day 20 ]On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
- Raltegravir Maximum Plasma Concentrations When Co-administered [ Time Frame: Day 20 ]On day 20 participants were administered raltegravir 400 mg and ribavirin 800 mg this was followed by intensive pharmacokinetic testing at 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, and 12 hours.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982553
|Imperial College Healthcare NHS Trust|
|London, United Kingdom, W2 1NY|
|Principal Investigator:||Alan Winston, MB BH||Imperial College London|