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NCT00000675 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT00000675 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants.
The verdict
NCT00000675, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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).
Interventions
- DRUG CD4-IgG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000675
The ClinicalTrials.gov registry entry for NCT00000675 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CD4-IgG is the first listed.
NCT00000675 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000675 about?
NCT00000675 is a clinical study titled "A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4 Immunoglobulin (rCd4-IgG) Administered by Intravenous Bolus in Patients With AIDS and AIDS Related Complex". 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 antiv...
What is the current status of trial NCT00000675?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants.
What interventions are being tested in trial NCT00000675?
The interventions under investigation include: CD4-IgG (DRUG).
Who is sponsoring clinical trial NCT00000675?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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