Pharmacokinetics (PK) Study of Once Daily Darunavir/Ritonavir and Twice and Once Daily Raltegravir in HIV-infected Subjects

Summary

The study aims to help us understand if the HIV drugs darunavir (taken with ritonavir) and raltegravir will affect each other when they are given at the same time. The purpose of the study is to assess the pharmacokinetics (how a drug is absorbed, distributed and eliminated from your body) of darunavir and ritonavir when these are taken with and without raltegravir. The duration of the study will be up to 50 days plus a screening visit which will take place up to 4 weeks prior to the start of the study, and a follow up visit which takes place 1-2 weeks after the last dose of study medication. Subjects will continue to take 2 of their usual drugs (those called nucleoside reverse transcriptase inhibitors -NRTI) throughout the study. For the first 21 days subjects will take their usual NRTI plus raltegravir 400mg twice daily. After this, subjects will also receive either: Group 1) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 400mg twice daily or Group 2) Darunavir/ritonavir 800mg/100mg once daily AND raltegravir 800mg once daily Subjects will take this regimen for 14 days. Subjects will be randomly allocated to either Group 1 or 2. You will have an equal (50/50) chance of being allocated to Group 1 or 2.

Timeline

Start

2009-06

Primary completion

2009-12

Completion

2009-12

Drugs

Indications