Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000628
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
A Pharmacokinetic Study of L-697661 Alone and in Combination With Zidovudine
Sponsor:
Merck Sharp Dohme LLC
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pharmacokinetic Study of L-697661 Alone and in Combination With Zidovudine
Status:
COMPLETED
Status Verified Date:
1994-10
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:
Part 1 To study the potential safety and pharmacokinetic blood level effects of zidovudine AZT on L-697661 to obtain additional pharmacokinetic information in humans with L-697661 to study the effect of L-697661 on hepatic enzyme induction Part 2 To begin a study of the antiviral activity of L-697661
L-697661 is a newly identified compound that inhibits HIV replication reproduction and growth in cell culture It works together with AZT against HIV
L-697661 is a newly identified compound that inhibits HIV replication reproduction and growth in cell culture It works together with AZT against HIV
Detailed Description:
L-697661 is a newly identified compound that inhibits HIV replication reproduction and growth in cell culture It works together with AZT against HIV
Part 1 Twelve patients are randomly assigned to one of two groups Group 1 patients receive AZT for 7 days followed by AZT plus L-697661 with food for 56 days Group 2 patients receive no drug for 7 days followed by L-697661 with food for 56 days Antipyrine is administered 1 hour prior to study drug on days 8 22 and 35
Part 2 Fifteen patients receive L-697661 with food for 8 weeks Therapy with L-697661 may be extended beyond 8 weeks for up to 24 weeks
Part 1 Twelve patients are randomly assigned to one of two groups Group 1 patients receive AZT for 7 days followed by AZT plus L-697661 with food for 56 days Group 2 patients receive no drug for 7 days followed by L-697661 with food for 56 days Antipyrine is administered 1 hour prior to study drug on days 8 22 and 35
Part 2 Fifteen patients receive L-697661 with food for 8 weeks Therapy with L-697661 may be extended beyond 8 weeks for up to 24 weeks
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 |
|---|---|---|---|
| Merck Protocol 020-00 | None | None | None |