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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Bonnie Brown       clinicaltrials@progenics.com

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

Study ID Numbers:  TT2001; 5R44-AI048278-05
Record last reviewed:  February 2003
Last Updated:  February 11, 2005
Record first received:  February 20, 2003
ClinicalTrials.gov Identifier:  NCT00055185
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08