Drug Interaction Study With Ribavirin and Abacavir in Male Subjects With Hepatitis C Who Have Failed Ribavirin Treatment

HIV Clinical Trial

Official title: Pharmacokinetic Interactions of Ribavirin and Abacavir in Hepatitis-C Mono-infected Male Subjects Who Previously Failed Ribavirin-based Treatment

Status Completed

Clinical Trial Summary

This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.

Clinical Trial Description

Abacavir is an anti-HIV drug that belongs to the class of nucleoside reverse transcriptase inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and ribavirin used in this study are also FDA approved.Some individuals who have HIV infection also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level of ribavirin in the body, in the blood and in cells named peripheral blood mononuclear cells (PBMC's). Thus, taking ribavirin and abacavir together could lead to treatment failure for hepatitis C. Therefore, it is important to understand whether ribavirin levels are affected when the two medications are taken together. ;

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV

• NCT number: NCT01052701
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Phase 1
• Start date: December 2009
• Completion date: December 2012