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NCT00000743 · ClinicalTrials.gov registry record · Phase 1

A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
64
Enrollment target

NCT00000743 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 64 participants.

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The verdict

NCT00000743, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
64 participants
Enrollment target

Study Summary

To determine the safety and tolerance of alvircept sudotox (sCD4-PE40) given at various dosing intervals and concentrations. To determine whether frequent dosing alters immunogenicity or toxicity. To obtain preliminary data to ascertain whether sCD4-PE40 has activity against HIV in human subjects. To determine whether there is any additive toxicity with combined use of sCD4-PE40 and zidovudine (AZT). There is some evidence that AZT and sCD4-PE40, an experimental drug with anti-HIV activity previously demonstrated in vitro, may produce increased benefit when used in combination in HIV-infected patients.

Interventions

  • DRUG Zidovudine
  • DRUG Alvircept sudotox

Trial Details

FieldValue
Enrollment Target 64 participants
Est. Completion 1995-05
Phase Phase 1

What the Registry Record Tells You About NCT00000743

The ClinicalTrials.gov registry entry for NCT00000743 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 64 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 2 interventions - of which Zidovudine is the first listed.

NCT00000743 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000743 about?

NCT00000743 is a clinical study titled "A Phase I, Dose-Escalating Safety and Tolerance Study of sCD4-PE40 in HIV-Infected Persons". To determine the safety and tolerance of alvircept sudotox (sCD4-PE40) given at various dosing intervals and concentrations. To determine whether frequent dosing alters immunogenicity or toxicity. To obtain preliminary data to ascertain whether sCD4-PE40 has activity against HIV in human subjects. T...

What is the current status of trial NCT00000743?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. Estimated completion is 1995-05.

What interventions are being tested in trial NCT00000743?

The interventions under investigation include: Zidovudine (DRUG), Alvircept sudotox (DRUG).

Who is sponsoring clinical trial NCT00000743?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.