Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002312
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of U-90152 in HIV-1 Infected Patients Who Take Zidovudine
Sponsor:
Pharmacia and Upjohn
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Open-Label Escalating Multiple-Dose Study of the Safety Tolerance and Pharmacokinetics of Oral U-90152 in HIV-1 Infected Males and Females With CD4 Counts of 200 - 500 Cellsmm3 Who Are Maintained on a Stable Dose of Zidovudine AZT
Status:
COMPLETED
Status Verified Date:
1994-04
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 evaluate the pharmacokinetics safety and tolerance of delavirdine mesylate U-90152 after multiple doses given orally to asymptomatic HIV-1 positive patients who are maintained on a stable dose of zidovudine AZT To investigate the optimum dose regimen of U-90152 that gives average trough concentrations 1 micromolar in combination with standard AZT therapy and to examine drug interactions between the two drugs To establish the MTD of U-90152 in HIV-1 positive patients on stable AZT therapy To investigate comparative pharmacokinetics between HIV-1 positive men and women
Detailed Description:
None
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 |
|---|---|---|---|
| M33310003 | None | None | None |