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NCT00001386 · ClinicalTrials.gov registry record · Phase 1

Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection

A Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
31
Enrollment target
1
Study location

NCT00001386 is a Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001386, a Phase 1 study of HIV Infection and Acquired Immunodeficiency Syndrome, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

Synthetic HIV Peptide Vaccines (Treatment Protocol) We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in combination) in patients with early HIV infection. Patients entered onto the study must have \>500 CD4 cells/mm(3) and have preserved cardiac, hepatic, renal, and bone marrow function. Patients must be off all anti-retroviral therapy for at least 6 months and may not have received any experimental HIV vaccines. The vaccines being testing in this trial are comprised of short peptide segments of the HIV envelope, including the V3 loop. In animal studies, the peptides were able to induce neutralizing antibodies as well as cytotoxic T responses to HIV. This will be the first trial in which they are given to humans. The study will last for approximately one year, during which time the volunteers will receive 6 peptide vaccines under the skin. For more information, please call Tino Merced-Galindez, R.N. at (301) 496-8959 or Dr. Richard Little at (800) 772-5464.

Conditions Studied

HIV Infection Acquired Immunodeficiency Syndrome

Interventions

  • DRUG PCLUS 3-18 MN
  • DRUG PCLUS 6.1 MN

Study Locations (1)

Maryland

  • National Cancer Institute (NCI) - Bethesda

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 1994-06
Est. Completion 2002-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT00001386

The ClinicalTrials.gov registry entry for NCT00001386 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 73 other HIV Infection trials with a reported enrollment target (87% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infection appearing as the primary indexed condition, and to 2 interventions - of which PCLUS 3-18 MN is the first listed.

NCT00001386 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001386 about?

NCT00001386 is a clinical study titled "Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With Synthetic HIV Envelope Peptides in Patients With Early Human Immunodeficiency Virus Infection". Synthetic HIV Peptide Vaccines (Treatment Protocol) We are conducting a study to evaluate the safety of two peptide vaccines (given alone or in combination) in patients with early HIV infection. Patients entered onto the study must have \>500 CD4 cells/mm(3) and have preserved cardiac, hepatic, ren...

What is the current status of trial NCT00001386?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 1994-06. Estimated completion is 2002-01.

What conditions does trial NCT00001386 study?

This clinical trial studies the following conditions: HIV Infection, Acquired Immunodeficiency Syndrome.

What interventions are being tested in trial NCT00001386?

The interventions under investigation include: PCLUS 3-18 MN (DRUG), PCLUS 6.1 MN (DRUG).

Who is sponsoring clinical trial NCT00001386?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001386 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.