Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002183
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Phase I Trial to Evaluate the Safety Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety Pharmacokinetics and Antiviral Activity of 141W94 After Multiple Dosing in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1997-07
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 assess the safety and tolerance of multiple oral doses of 141W94 alone in combination with 1592U89 and in combination with Retrovir and Epivir administered to patients with HIV infection as measured by the development of clinical adverse experiences and laboratory test abnormalities To determine the steady-state pharmacokinetics of 141W94 alone and in combination with 1592U89 after multiple oral dosing To obtain preliminary evidence of antiretroviral activity of 141W94 alone and in combination with 1592U89 the antiretroviral effect of combined RetrovirEpivir and the antiretroviral effect of 141W94 when added to RetrovirEpivir or to 1592U89RetrovirEpivir
Detailed Description:
60 HIV-infected patients will be sequentially assigned to receive 1 of 5 doses of 141W94 alone or 141W94 plus 1592U89 After each patient has completed 4 weeks of the assigned regimen Phase A the patient will receive Epivir and Retrovir for up to 8 months Phase B Patients originally assigned in Phase A to receive 141W94 and 1592U89 continue to receive 1592U89 during this period Upon termination of Phase B 141W94 is added to existing regimens of Phase B Phase C Phase C will last for 12 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?: