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NCT00000984 · ClinicalTrials.gov registry record · Phase 1

A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection

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

Completed
Registry status
Phase 1
Development phase
40
Enrollment target
6
Study locations

NCT00000984 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 40 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT00000984, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target
6
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG CD4 Antigens

Study Locations (6)

California

  • Northern California Pediatric AIDS Treatment Ctr / UCSF - San Francisco
  • Stanford Univ School of Medicine / Pediatrics - Stanford

Illinois

  • Chicago Children's Memorial Hosp - Chicago
  • Children's Memorial Med Ctr - Chicago

New Jersey

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

North Carolina

  • Duke Univ Med Ctr - Durham

Trial Details

FieldValue
Enrollment Target 40 participants
Phase Phase 1

What the Registry Record Tells You About NCT00000984

The ClinicalTrials.gov registry entry for NCT00000984 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). 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 1 condition, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which CD4 Antigens is the first listed.

NCT00000984 reports 6 study locations spanning 4 distinct geographic areas - top geographies include California, Illinois, New Jersey.

Frequently Asked Questions

What is clinical trial NCT00000984 about?

NCT00000984 is a clinical study titled "A Phase I Study of the Safety and Pharmacokinetics of Recombinant CD4 (rCD4) in Infants and Children Infected With or at Risk for HIV Infection". 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. rC...

What is the current status of trial NCT00000984?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants.

What conditions does trial NCT00000984 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000984?

The interventions under investigation include: CD4 Antigens (DRUG).

Who is sponsoring clinical trial NCT00000984?

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

Where is trial NCT00000984 being conducted?

This trial has 6 study locations across California, Illinois, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.