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

NCT ID: NCT00055185

Last Updated: 2008-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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

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HIV Infections Acquired Immune Deficiency Syndrome

Keywords

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Treatment Experienced

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CD4-IgG2 (PRO 542)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Progenics Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jeffery M Jocbson, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medical Center

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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5R44AI048278-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TT2001

Identifier Type: -

Identifier Source: org_study_id