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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Progenics Pharmaceuticals, Inc.
• Treatments: CD4 Immunoadhesins

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