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

Completed · Phase 2

Conditions studied: HIV Infections, Acquired Immune Deficiency Syndrome

In brief

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.

Key facts

Study ID

NCT00055185

Run by

Progenics Pharmaceuticals, Inc.

People needed

24

Starts

2003-04-01

Expected to finish

2005-06-01

Last updated by the study team

2008-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Beth Israel Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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