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

February 20, 2003
October 2, 2008
April 2003
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Complete list of historical versions of study NCT00055185 on ClinicalTrials.gov Archive Site
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Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
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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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Acquired Immune Deficiency Syndrome
Drug: CD4-IgG2 (PRO 542)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2005
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00055185
TT2001, 5R44-AI048278-05
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Progenics Pharmaceuticals, Inc.
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Principal Investigator: Jeffery M Jocbson, MD Beth Israel Medical Center
Progenics Pharmaceuticals, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP