Viewing Study NCT00000634



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Last Modification Date: 2024-10-26 @ 9:02 AM
Study NCT ID: NCT00000634
Status: COMPLETED
Last Update Posted: 2011-03-01
First Post: 1999-11-02

Brief Title: A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: A Pilot Pharmacokinetic Phase I Evaluation of BI-RG-587 in HIV-Infected Children
Status: COMPLETED
Status Verified Date: 2011-02
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 generate initial information on the pharmacokinetics blood levels and dose proportionality of nevirapine BI-RG-587 plasma levels in HIV-infected children to assess the safety and tolerance of single rising oral doses of nevirapine in HIV-infected children and to confirm that the single doses that achieve certain plasma levels in adults achieve similar levels in HIV-infected children

Test tube studies have shown that nevirapine BI-RG-587 inhibits replication reproduction of HIV Nevirapine works with zidovudine AZT and is active against strains of the virus that are resistant to AZT Studies of the drug in HIV-infected adults showed no serious adverse effects
Detailed Description: Test tube studies have shown that nevirapine BI-RG-587 inhibits replication reproduction of HIV Nevirapine works with zidovudine AZT and is active against strains of the virus that are resistant to AZT Studies of the drug in HIV-infected adults showed no serious adverse effects

Two doses given by mouth are evaluated Three patients receive the lower dose and 7 days after the third patient receives the lower dose three additional patients receive the higher dose After dosing blood is drawn at 1 2 4 8 24 48 96 168 hours to measure blood levels of the drug

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
00853 None None None