- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055185
Safety and Efficacy of PRO 542 in the Treatment of HIV-Infected Patients
October 2, 2008 updated by: Progenics Pharmaceuticals, Inc.
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10003
- Beth Israel Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffery M Jocbson, MD, Beth Israel Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
June 1, 2005
Study Registration Dates
First Submitted
February 20, 2003
First Submitted That Met QC Criteria
February 20, 2003
First Posted (Estimate)
February 21, 2003
Study Record Updates
Last Update Posted (Estimate)
October 3, 2008
Last Update Submitted That Met QC Criteria
October 2, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
- Physiological Effects of Drugs
- Immunologic Factors
- CD4 Immunoadhesins
Other Study ID Numbers
- TT2001
- 5R44AI048278-05 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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