Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000393
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2000-01-17
Brief Title:
A Phase I Trial of Peptide T Efficacy for the Neuropsychiatric Complications of Acquired Immunodeficiency Syndrome AIDS
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 toxicology and activity of Peptide T D-Ala-1-peptide-T-amide in humans and to find out more about the ability of peptide T to prevent halt andor reverse AIDS-associated immunologic disturbances
Recent information suggests that the central nervous system CNS is often impaired in HIV-infected individuals The dysfunction of the CNS may be either a direct or an indirect result of HIV infection One method to prevent HIV infection is to block entry of the virus into the cells of the body Peptide T shows laboratory evidence of blocking the entrance of HIV into cells that are susceptible to HIV infection Studies that have been done indicate that peptide T is nontoxic in the doses that are used in this study
AIDS patients with minimal group 1 or moderate group 2 cognitive dysfunction mental impairment receive an increasing schedule of three dosage levels of peptide T All patients receive an intravenous IV dose of peptide T for 10 days followed by the intermediate dose and then the highest dose each intravenously for 10 days Following successful completion of 3 IV doses four patients participate in an intranasal pharmacokinetic blood level study dosage trial of 3 doses different from IV of peptide T once for each of 3 successive days Follow-up continues for up to 1 year
Recent information suggests that the central nervous system CNS is often impaired in HIV-infected individuals The dysfunction of the CNS may be either a direct or an indirect result of HIV infection One method to prevent HIV infection is to block entry of the virus into the cells of the body Peptide T shows laboratory evidence of blocking the entrance of HIV into cells that are susceptible to HIV infection Studies that have been done indicate that peptide T is nontoxic in the doses that are used in this study
AIDS patients with minimal group 1 or moderate group 2 cognitive dysfunction mental impairment receive an increasing schedule of three dosage levels of peptide T All patients receive an intravenous IV dose of peptide T for 10 days followed by the intermediate dose and then the highest dose each intravenously for 10 days Following successful completion of 3 IV doses four patients participate in an intranasal pharmacokinetic blood level study dosage trial of 3 doses different from IV of peptide T once for each of 3 successive days Follow-up continues for up to 1 year
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