Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients

NCT00055185•Progenics Pharmaceuticals, Inc.

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Beth Israel Medical Center

New York, New York, United States

Key Dates

Start Date

April 1, 2003

Completion Date

June 1, 2005

Last Updated

October 3, 2008

Enrollment

Estimated participants

Conditions

HIV InfectionsAcquired Immune Deficiency Syndrome

Interventions

CD4-IgG2 (PRO 542)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2008Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients

Inclusion Criteria

Exclusion Criteria

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