Expired Study
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New York, New York 10003


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Confirmed diagnosis of HIV - Patients must be on a stable dose of acceptable anti-HIV therapy or receiving no anti-HIV therapy for at least four (4) weeks prior to the start of this study - HIV-1 determination by RNA-PCR greater than or equal to 100,000 copies/ml - CD4 count >50/cubic mm at screening Exclusion Criteria: - Patients who have previously received PRO 542 - Patients with active, significant infection (other than HIV) not controlled by antibiotics - Pregnant or lactating women - Patients with an estimated life expectancy of <3 months - Patients currently receiving steroids or other immunosuppressive therapy or immunoglobulin therapy except for topical or inhaled steroids - Patients with known allergy or hypersensitivity to PRO 542 or immunoglobulin preparations


NCT ID:

NCT00055185


Primary Contact:

Principal Investigator
Jeffery M Jocbson, MD
Beth Israel Medical Center


Backup Contact:

N/A


Location Contact:

New York, New York 10003
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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