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NCT00000762 · ClinicalTrials.gov registry record · Phase 1

A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection

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

Completed
Registry status
Phase 1
Development phase
72
Enrollment target

NCT00000762 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 72 participants.

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The verdict

NCT00000762, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
72 participants
Enrollment target

Study Summary

To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age. The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomatic HIV-infected children a therapy currently being tested in their adult counterparts, in the hope of forestalling the progression of HIV immunosuppression and clinical disease.

Interventions

  • BIOLOGICAL rgp120/HIV-1MN
  • BIOLOGICAL rgp120/HIV-1 SF-2
  • BIOLOGICAL gp160 Vaccine (MicroGeneSys)

Trial Details

FieldValue
Enrollment Target 72 participants
Est. Completion 1996-02
Phase Phase 1

What the Registry Record Tells You About NCT00000762

The ClinicalTrials.gov registry entry for NCT00000762 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 72 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 3 interventions - of which rgp120/HIV-1MN is the first listed.

NCT00000762 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000762 about?

NCT00000762 is a clinical study titled "A Placebo-Controlled, Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant Envelope Proteins of HIV-1 gp160 and gp120 in Children >= 1 Month Old With Asymptomatic HIV Infection". To determine the safety and immunogenicity of gp160 (MicroGeneSys), rgp120/HIV-1MN (Genentech), and rgp120/HIV-1SF2 (BIOCINE) and their adjuvants in HIV-infected children 1 month to 18 years of age. The initiation of this immunotherapy trial will provide multiple benefits by assessing in asymptomat...

What is the current status of trial NCT00000762?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. Estimated completion is 1996-02.

What interventions are being tested in trial NCT00000762?

The interventions under investigation include: rgp120/HIV-1MN (BIOLOGICAL), rgp120/HIV-1 SF-2 (BIOLOGICAL), gp160 Vaccine (MicroGeneSys) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000762?

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

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