Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000391
Status:
COMPLETED
Last Update Posted:
2015-03-03
First Post:
2000-01-17
Brief Title:
A Phase I Trial of Intranasal Peptide T Safety Toxicity and Pharmacokinetics in Human Immunodeficiency Virus-1 HIV-1 Infected Patients
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
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:
To study the safety and toxicity of intranasal peptide T D-Ala-1-peptide-T-amide in humans and to find out how quickly and how much of a given dose enters the bloodstream and how quickly it leaves the bloodstream To obtain information on the ability of intranasal peptide T to prevent halt andor reverse the effects of AIDS on the central nervous system
Studies have shown that AIDS is caused by a retrovirus This virus works by inactivating or destroying human CD4 cells which are part of the human immune system This in turn leads to the observed immunologic defects and related illnesses including HIV encephalopathy disease of the brain One method of preventing AIDS is to prevent HIV from entering the cell HIV binds to the receptor CD4 site Peptide T also binds to this site and thus by competing for that site can block the binding of the virus to its receptor Preliminary animal and human studies indicate that peptide T is safe at the doses selected for this trial
Thirty patients with AIDS or AIDS related complex ARC are entered into the study to receive an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug All patients receive an initial intravenous test dose of peptide T The test dose is administered over 1 hour followed by an observation period of 8 hours in the outpatient clinic
Studies have shown that AIDS is caused by a retrovirus This virus works by inactivating or destroying human CD4 cells which are part of the human immune system This in turn leads to the observed immunologic defects and related illnesses including HIV encephalopathy disease of the brain One method of preventing AIDS is to prevent HIV from entering the cell HIV binds to the receptor CD4 site Peptide T also binds to this site and thus by competing for that site can block the binding of the virus to its receptor Preliminary animal and human studies indicate that peptide T is safe at the doses selected for this trial
Thirty patients with AIDS or AIDS related complex ARC are entered into the study to receive an increasing schedule of three dosage levels of intranasal peptide T for 12 - 16 weeks followed by a 1-month off-drug follow-up period and a subsequent 1-month return to the drug All patients receive an initial intravenous test dose of peptide T The test dose is administered over 1 hour followed by an observation period of 8 hours in the outpatient clinic
Detailed Description:
None
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