NCT00000663

Brief Summary

To determine the safety profile, assess pharmacokinetic properties (blood levels), and obtain preliminary indication of the antiviral and immunologic effects of recombinant CD4 immunoglobulin G (CD4-IgG). CD4-IgG may be effective in blocking HIV transmission and spread, that is, CD4-IgG has antiviral effects. Studies done in adult patients with AIDS and AIDS related complex (ARC) have shown that rCD4 can be safely administered by intravenous bolus, intramuscular or subcutaneous injection. No serious or dose-limiting, drug-related toxicities have been observed to date.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

7 active sites

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

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 1996

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Recombinant ProteinsInjections, IntravenousIgGDrug EvaluationAcquired Immunodeficiency SyndromeAntigens, CD4Carrier Proteins

Interventions

CD4-IgGDRUG

Eligibility Criteria

Age1 Day - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients must have the following:
  • HIV-1 infection, or if less than 15 months old, born to mother with HIV-1 infection.
  • Legally qualified guardian with the ability to sign a written, informed consent form.
  • Willingness to abstain from all other experimental therapy for HIV-1 infection during the first 12 weeks of the study period.
  • Anticipated life expectancy of at least 3 months.
  • Prior Medication:
  • Allowed:
  • Prophylactic anti-Pneumocystis carinii pneumonia (PCP) or antifungal therapy.
  • Gamma globulin as prophylaxis for measles and varicella.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Past or present history of neurological abnormalities including withdrawal syndrome or seizures.
  • Past or present history of any serious active opportunistic infection including Pneumocystis carinii pneumonia (PCP).
  • Echocardiogram values \> 2 standard deviations from normal.
  • Hematologic, renal, or hepatic insufficiency.
  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Intravenous gamma globulin (IVIG) except as prophylaxis for measles and varicella.
  • Cancer chemotherapy.
  • Corticosteroids.
  • Other known immunomodulatory agents.
  • Other experimental therapy not specifically allowed.
  • Patients with the following are excluded:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

UCSD Treatment Ctr

San Diego, California, 92103, United States

Location

Univ of Miami School of Medicine

Miami, Florida, 33136, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Tulane Univ Med School

New Orleans, Louisiana, 70112, United States

Location

North Shore Univ Hosp

Great Neck, New York, 11021, United States

Location

Columbia Univ Babies' Hosp

New York, New York, 10032, United States

Location

Texas Children's Hosp / Baylor Univ

Houston, Texas, 77030, United States

Location

Related Publications (2)

  • Weintrub P, Yogev R, Conner E, Wilfert K, Mordenti J, Ammann AJ. Safety and pharmacokinetics of recombinant CD4 in children with HIV infection. Int Conf AIDS. 1990 Jun 20-23;6(2):95 (abstract no FB23)

    BACKGROUND

  • Shearer WT, Israel RJ, Starr S, Fletcher CV, Wara D, Rathore M, Church J, DeVille J, Fenton T, Graham B, Samson P, Staprans S, McNamara J, Moye J, Maddon PJ, Olson WC. Recombinant CD4-IgG2 in human immunodeficiency virus type 1-infected children: phase 1/2 study. The Pediatric AIDS Clinical Trials Group Protocol 351 Study Team. J Infect Dis. 2000 Dec;182(6):1774-9. doi: 10.1086/317622. Epub 2000 Oct 27.

    PMID: 11069253BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

CD4 Immunoadhesins

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

Intervention Hierarchy (Ancestors)

Cell Adhesion MoleculesMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant ProteinsAntigens, SurfaceAntigensBiological Factors

Study Officials

  • R Yogev

    STUDY CHAIR

  • W Shearer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1996-10

Locations

US(7)