Ignite Creation Date:
2024-05-05 @ 11:20 AM
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
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
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 |