NCT00000984

Brief Summary

AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled. Original design: To determine whether the experimental drug recombinant CD4 (rCD4), which is produced through genetic engineering technology, is safe and well-tolerated in children infected with or at risk for HIV infection. rCD4 may be an effective treatment for HIV infection, based on its ability to block infection of human cells by HIV in laboratory tests. However, the activity of rCD4 still needs to be confirmed in clinical trials. It is hoped that these tests will show that rCD4 is both safe and effective in treating children who are infected with or who are at risk for infection with HIV.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

6 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 ProteinsAcquired Immunodeficiency SyndromeAntigens, CD4Antiviral Agents

Interventions

CD4 AntigensDRUG

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • Prophylactic medication for patients with previous documented episodes of Pneumocystis carinii pneumonia (PCP).
  • Concomitant zidovudine (AZT) or intravenous gamma globulin (IVIG) during maintenance therapy phase of the study.
  • AMENDED: As of 10/19/90 only Children 0 to 3 months are being enrolled.
  • Original design: Patients must be infected with HIV or at risk for HIV infection. They must be one of the following:
  • Asymptomatic.
  • Mildly symptomatic but not eligible for and/or decline ACTG protocol 052.
  • Markedly symptomatic but not eligible for and/or decline ACTG protocol 051 or cannot tolerate zidovudine (AZT) therapy.
  • All patients must have:
  • A life expectancy of at least 3 months.
  • A legally-qualified guardian with the ability to sign a written informed consent form, which must be obtained prior to treatment. A willingness to abstain from all other experimental therapy for HIV infection during the entire study period.

You may not qualify if:

  • Concurrent Medication:
  • Excluded:
  • Zidovudine (AZT).
  • Intravenous gamma globulin (IVIG).
  • Pentamidine.
  • Trimethoprim / sulfamethoxazole (TMP/SMX).
  • Corticosteroids.
  • Nonsteroidal anti-inflammatory agents (NSAIDS).
  • Other known immunomodulatory agents.
  • All other experimental therapies.
  • Patients will be excluded from the study for the following reasons:
  • Serious active opportunistic infection or malignancies prior to study entry.
  • Defined organ insufficiencies.
  • Prior Medication:
  • Excluded within 3 weeks of study entry:
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Northern California Pediatric AIDS Treatment Ctr / UCSF

San Francisco, California, 94143, United States

Location

Stanford Univ School of Medicine / Pediatrics

Stanford, California, 943054149, United States

Location

Chicago Children's Memorial Hosp

Chicago, Illinois, 606143394, United States

Location

Children's Memorial Med Ctr

Chicago, Illinois, 60614, United States

Location

Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

Newark, New Jersey, 071072198, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 277103499, United States

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

CD4 Antigens

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)

Receptors, Interleukin-16Receptors, InterleukinReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, HIVReceptors, VirusAntigens, Differentiation, T-LymphocyteAntigens, DifferentiationAntigens, SurfaceAntigensBiological FactorsBiomarkers

Study Officials

  • P Weintrub

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
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(6)