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NCT00000827 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children

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

Completed
Registry status
Phase 1
Development phase
45
Enrollment target

NCT00000827: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000827 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 45 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000827, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
45 participants
Enrollment target

Study Summary

To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufactured from HIV antibody-rich plasma taken from asymptomatic donors. It is hypothesized that HIVIG will decrease the viral burden of moderately advanced HIV-positive children.

Interventions

  • DRUG Anti-HIV Immune Serum Globulin (Human)

Trial Details

FieldValue
Enrollment Target 45 participants
Est. Completion 1998-04
Phase Phase 1

What the finished NCT00000827 record still lists

NCT00000827 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% lower).

The record links to 0 conditions, and to 1 intervention - of which Anti-HIV Immune Serum Globulin (Human) is the first listed.

NCT00000827 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000827 about?

NCT00000827 is a clinical study titled "A Phase I/II Study of Hyperimmune IVIG in Slowing Progression of Disease in HIV-Infected Children". To evaluate the safety, tolerance, pharmacokinetics, and antiviral activity of human anti-HIV immune serum globulin ( HIVIG ) at three dosage levels in HIV-infected children. Passive antibody therapy has been used with limited success in treating advanced HIV disease in adults. HIVIG is manufacture...

What is the current status of trial NCT00000827?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. Estimated completion is 1998-04.

What interventions are being tested in trial NCT00000827?

The interventions under investigation include: Anti-HIV Immune Serum Globulin (Human) (DRUG).

Who is sponsoring clinical trial NCT00000827?

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

How this trial's enrollment target compares

Where NCT00000827's enrollment target sits among peer trials

45 1066th of 2000 higher than 915 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000827, the US trial registry maintained by the National Library of Medicine. NCT00000827 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.