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

HIV Infections Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055185
• Other study ID #: TT2001
• Secondary ID: 5R44AI048278-05
• Status: Completed
• Phase: Phase 2
• First received: February 20, 2003
• Last updated: October 2, 2008
• Start date: April 2003
• Est. completion date: June 2005

Study information

• Verified date: October 2008
• Source: Progenics Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immune Deficiency Syndrome
• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• CD4-IgG2 (PRO 542)

Locations

Country	Name	City	State
United States	Beth Israel Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Progenics Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,