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NCT00000822 · ClinicalTrials.gov registry record · Phase 1

A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

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

Completed
Registry status
Phase 1
Development phase
46
Enrollment target
1
Study location

NCT00000822 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 46 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00000822, 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
46 participants
Enrollment target
1
Study location

Study Summary

To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respond to the first 7 injections when they are boosted every 8 weeks for an additional 6-12 months \[AS PER AMENDMENT 11/12/96: stratum 1 patients only\]. To describe the ability of the immunogen to induce a response after an additional 6-12 months of injections among patients who did not respond to the first 7 injections \[AS PER AMENDMENT 11/12/96: stratum 1 patients only\]. HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression.

Conditions Studied

HIV Infections

Interventions

  • DRUG Ritonavir
  • BIOLOGICAL gp160 Vaccine (Immuno-AG)
  • DRUG Stavudine
  • DRUG Didanosine

Study Locations (1)

California

  • Stanford CRS - Stanford

Trial Details

FieldValue
Enrollment Target 46 participants
Est. Completion 1999-05
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000822

The ClinicalTrials.gov registry entry for NCT00000822 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 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 (90% 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 4 interventions - of which Ritonavir is the first listed.

NCT00000822 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT00000822 about?

NCT00000822 is a clinical study titled "A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells". To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific antibody responses, and DTH reaction. To describe the durability of the immunogen in patients who respo...

What is the current status of trial NCT00000822?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. Estimated completion is 1999-05.

What conditions does trial NCT00000822 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00000822?

The interventions under investigation include: Ritonavir (DRUG), gp160 Vaccine (Immuno-AG) (BIOLOGICAL), Stavudine (DRUG), Didanosine (DRUG).

Who is sponsoring clinical trial NCT00000822?

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 NCT00000822 being conducted?

This trial has 1 study location across California. 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.