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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CD4-IgG2 (PRO 542)

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Treatment Experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Beth Israel Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00055185

First Posted

February 20, 2003

Last Updated

October 2, 2008

Sponsor

Progenics Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00055185

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Progenics Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, Acquired Immune Deficiency Syndrome

Keywords

Treatment Experienced

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

CD4-IgG2 (PRO 542)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffery M Jocbson, MD

Organizational Affiliation

Beth Israel Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beth Israel Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10003

Country

United States

HIV Infections, Acquired Immune Deficiency Syndrome

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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