NCT00000675

Brief Summary

To study the safety and pharmacokinetics (blood levels) of recombinant human CD4 immunoglobulin (rCd4-IgG) in patients with AIDS or AIDS related complex (ARC) who have failed or declined therapy with zidovudine (AZT). An additional goal of the study is to obtain a preliminary indication of the antiviral effects of Cd4-IgG in patients with AIDS or ARC. Other approaches in addition to existing treatment of HIV infection need to be evaluated. One approach may be to block HIV infection by interrupting the assembly of the virus within the cell or the budding of virus from the membrane of the infected cell. In addition, blocking the attachment of HIV to its cellular receptor may offer another point of attack. HIV binds to the CD4 receptor on the target T4 lymphocyte and the envelope glycoprotein of the virus (gp120) is capable of high affinity binding to CD4. Any agent that prevents the attachment of gp120 to the CD4 receptor should be able to block virus transmission and spread. Recently, scientists have succeeded in producing highly purified recombinant soluble human CD4. Recombinant CD4 is capable of binding to HIV envelope protein (gp120) and inhibiting HIV infectivity in test tube studies. Potential therapeutic benefit in patients with HIV infection could be derived from either or both of these biologic effects. In order to extend the length of time that rCD4 stays in the body, the compound has been modified by combining it with a human immunoglobulin of the IgG1 class (IgG).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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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

January 1, 1991

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

Recombinant ProteinsIgGDrug EvaluationAcquired Immunodeficiency SyndromeAntigens, CD4AIDS-Related ComplexCarrier Proteins

Interventions

CD4-IgGDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must fulfill the following criteria:
  • Diagnosis of AIDS or AIDS-related complex, according to CDC criteria, in previously documented HIV seropositive individuals.
  • Failure to tolerate or respond to zidovudine (AZT) therapy for HIV infection or a decision to decline such therapy.
  • Willingness to abstain from all other experimental therapy for HIV infection during study period.
  • Life expectancy of at least 3 months.
  • Patients must be able to sign a written informed consent form.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following are excluded:
  • Serious active opportunistic infection or malignancies not specifically allowed.
  • Concurrent Medication:
  • Excluded:
  • Oral or intravenous acyclovir for herpes.
  • Zidovudine (AZT).
  • Interferon.
  • Corticosteroids.
  • Nonsteroidal anti-inflammatory agents (NSAIDS).
  • Intravenous acyclovir.
  • Other known immunomodulatory agents.
  • Other experimental therapy.
  • Patients with the following are excluded:
  • Serious active opportunistic infection or malignancies not specifically allowed.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford Univ School of Medicine

Stanford, California, 94305, United States

Location

Univ of Washington

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • Collier AC, Coombs RW, Katzenstein D, Holodniy M, Gibson J, Mordenti J, Izu AE, Duliege AM, Ammann AJ, Merigan T, et al. Safety, pharmacokinetics, and antiviral response of CD4-immunoglobulin G by intravenous bolus in AIDS and AIDS-related complex. J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Oct 1;10(2):150-6. doi: 10.1097/00042560-199510020-00006.

    PMID: 7552478BACKGROUND

  • Collier A, Katzenstein D, Coombs R, Holodniy M, Mordenti J, Arditti D, Ammann A, Merigan T, Corey L. Safety and pharmacokinetics of intravenous recombinant CD4 immunoadhesin (RCD4-IGG) (AIDS Clinical Trials Group Protocol 121). Int Conf AIDS. 1990 Jun 20-23;6(3):206 (abstract no SB480)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeAIDS-Related Complex

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

  • L Corey

    STUDY CHAIR

  • A Collier

    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: 1991-01

Locations

US(2)