Trial Information

Summary: A Phase I, Parallel, Open-Label, Multicenter, Two Week, Repeat-dose Study Evaluating Plasma Amprenavir Pharmacokinetics in HIV-1-Infected Adult Subjects with Mild or Moderate Hepatic Impairment Receiving Fosamprenavir + Ritonavir Compared to Matched Control Subjects with Normal Hepatic Function [APV10017]

This research study is for patients who are HIV positive and are already taking an anti-HIV medication. There are two medications in this study: FPV (Fosamprenavir, Lexiva, Telzir) and RTV (Ritonavir, Norvir and all patients in this study will receive medication. FPV in the tablet form and RTV are FDA-approved. However, FPV in the liquid oral form is not FDA-approved.
All study medications and procedures will be provided for free and patients will be reimbursed for time and travel expenses. Participation will last about 6 weeks and there will be about 9 clinic visits. One of the visits will last up to 14 hours.
Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate if you
-are male or female 18-65 years old
-are HIV positive
-are currently taking an anti-HIV medication
-meet additional criteria

You will not be eligible to participate if you
-are pregnant or breastfeeding
-have current active hepatitis
-have a recent history of drug or alcohol abuse

If you would like to learn more about participating in this study, please send an e-mail message using the form below.