Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
The purpose of this study is to determine any adverse effects of PRO 542 after administration and to determine the anti-HIV effects of PRO 542 in the patient.
Acquired Immune Deficiency Syndrome
Drug: CD4-IgG2 (PRO 542)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Start Date:||April 2003|
|Study Completion Date:||June 2005|
A 2 arm study involving a series of 3 triweekly doses of PRO 542. One arm will involve patients on a stable dose of anti-retroviral therapy and the other arm will consist of patients not receiving anti-retroviral therapy. Three patients will be enrolled in each arm followed by a safety evaluation. Following the safety evaluation, 3 more patients may be enrolled in each arm. After the first 12 patients, an additional 12 patients may be enrolled pending safety data.
|United States, New York|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Jeffery M Jocbson, MD||Beth Israel Medical Center|