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NCT00000956 · ClinicalTrials.gov registry record · Phase 1

A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

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

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
2
Study locations

NCT00000956 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 25 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT00000956, 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
25 participants
Enrollment target
2
Study locations

Study Summary

To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine indicates that, although serum anti-gp160 antibody responses were detected, the level and duration of those responses were limited. A preliminary observation suggests that weak functional antibody responses may develop following the 18 month booster of 40 or 80 mcg; therefore, a dose of gp160 vaccine having potentially greater immunogenicity is of particular interest.

Conditions Studied

HIV Infections

Interventions

  • BIOLOGICAL gp160 Vaccine (MicroGeneSys)

Study Locations (2)

Missouri

  • St. Louis Univ. School of Medicine AVEG - St Louis

Pennsylvania

  • JHU AVEG - Pittsburgh

Trial Details

FieldValue
Enrollment Target 25 participants
Est. Completion 1993-03
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000956

The ClinicalTrials.gov registry entry for NCT00000956 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 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 (94% 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 gp160 Vaccine (MicroGeneSys) is the first listed.

NCT00000956 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Missouri, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00000956 about?

NCT00000956 is a clinical study titled "A Phase I Multicenter Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160". To evaluate the safety and immune response to 640 and 1280 mcg HIV-1 recombinant envelope glycoprotein gp160. To evaluate the duration of antibody response and its relationship to dose and frequency of inoculation. Evaluation of previous patients who received doses of 40 or 80 mcg gp160 vaccine ind...

What is the current status of trial NCT00000956?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. Estimated completion is 1993-03.

What conditions does trial NCT00000956 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000956?

The interventions under investigation include: gp160 Vaccine (MicroGeneSys) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00000956?

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 NCT00000956 being conducted?

This trial has 2 study locations across Missouri, Pennsylvania. 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.