Viewing Study NCT00001386



Ignite Creation Date: 2024-05-05 @ 10:00 AM
Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00001386
Status: COMPLETED
Last Update Posted: 2008-03-04
First Post: 1999-11-03

Brief Title: 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
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: 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
Status: COMPLETED
Status Verified Date: 2002-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 cellsmm3 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 RN at 301 496-8959 or Dr Richard Little at 800 772-5464
Detailed Description: Assessment of toxicity and immunogenicity of two HIV-1 derived peptide vaccines in Montanide ISA-51 incomplete Freunds adjuvant given singly and in combination

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
94-C-0159 None None None