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

This study has been completed.
Sponsor:
Information provided by:
Progenics Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00055185
First received: February 20, 2003
Last updated: October 2, 2008
Last verified: October 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Progenics Pharmaceuticals, Inc.:
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014