NCT00055185

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (planned)
• Sponsor: Progenics Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• HIV Infections
• Acquired Immune Deficiency Syndrome

Interventions

Type	Name	Description
DRUG	CD4-IgG2 (PRO 542)

Timeline

• Start date: 2003-04-01
• Completion: 2005-06-01
• First posted: 2003-02-21
• Last updated: 2008-10-03

Locations

1 site across 1 country: United States