Trial Information

Summary: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Of A Novel CCR5 Antagonist, UK 427,857, in Combination with Optimized Background Therapy versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV 1 Infected Subjects [A4001028]

The purpose of this study is to see how safe and effective the study drug UK-427,857 is in treating people with HIV. UK-427,857 will be given in combination with Optimized Background Therapy (OBT). OBT is the medical care you would receive if you were not participating in this study. This study is considered research because the study drug UK 427, 857 has not been approved by the FDA. In this study, neither the patients or the study doctor will know if the patients are receiving UK 427, 857 or placebo (a pill with no active medication). Participants will be assigned a treatment by chance, 4 out of 5 people will receive the the study drug. Participation may last up to 48 weeks which includes about 13 clinic visits.
All test and procedures will be provided at no cost to you.
No Compensation Provided

Patient Inclusion/Exclusion Criteria:

You may be eligible to participate if you:
-are a male or female at least 18 years old
-are HIV positive
-meet additional criteria

You will not be able to participate if you:
-are pregnant or breastfeeding
-have cirrhosis of the liver
-have been diagnosed with hepatitis or pancreatitis within the past 30 days

Contact:

Mona Yacoub, MD
Mount Sinai Medical Center
One Gustave L. Levy Place

New York, NY 10029
Telephone: 212-241-6521
Fax: 212-523-6844
Email:

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

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Trial listings updated: June 1, 2008 at 5:45:36 AM


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