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

This study has been completed.

Sponsored by:	Progenics Pharmaceuticals, Inc.
Information provided by:	Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00055185

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.

Condition	Intervention	Phase
HIV Infections Acquired Immune Deficiency Syndrome	Drug: CD4-IgG2 (PRO 542)	Phase II

MedlinePlus related topics: AIDS

Drug Information available for: Proline PRO 542

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Progenics Pharmaceuticals, Inc.:

Estimated Enrollment:	24
Study Start Date:	April 2003
Study Completion Date:	June 2005

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055185

Locations

United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003

Sponsors and Collaborators

Progenics Pharmaceuticals, Inc.

Investigators

Principal Investigator:

Jeffery M Jocbson, MD

Beth Israel Medical Center

More Information

Study ID Numbers:	TT2001, 5R44-AI048278-05
Study First Received:	February 20, 2003
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00055185
Health Authority:	United States: Food and Drug Administration

Keywords provided by Progenics Pharmaceuticals, Inc.:

Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
CD4 Immunoadhesins
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Pathologic Processes
Disease
Slow Virus Diseases

Immune System Diseases
Syndrome
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009