NCT00055185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 hiv-infections

Timeline
Completed

Started Apr 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2003

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

October 3, 2008

Status Verified

October 1, 2008

First QC Date

February 20, 2003

Last Update Submit

October 2, 2008

Conditions

HIV InfectionsAcquired Immune Deficiency Syndrome

Keywords

Treatment Experienced

Interventions

CD4-IgG2 (PRO 542)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

CD4-IgG(2)

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Jeffery M Jocbson, MD

    Beth Israel Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 20, 2003

First Posted

February 21, 2003

Study Start

April 1, 2003

Study Completion

June 1, 2005

Last Updated

October 3, 2008

Record last verified: 2008-10

Locations

US(1)