Conditions: Hepatitis C HIV
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 26
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: Ribavirin plus Abacavir Administration intervention arm 2: Ribavirin alone administration

Interventions: intervention 1: Ribavirin intervention 2: Ribavirin plus Abacavir (ABC)
Intervention descriptions: intervention 1: Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)

OR

Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg) intervention 2: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)

OR

Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg)

Plus

Daily Abacavir 300 mg orally every 12 hours

Protocol document: