Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002338
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of 935U83 in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase I Trial to Evaluate the Safety Tolerance and Pharmacokinetics of 935U83 After Multiple Dosing in Patients With HIV Infection
Status:
COMPLETED
Status Verified Date:
1996-04
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 assess the safety tolerance and steady-state pharmacokinetics of multiple oral doses of 935U83 administered to patients with HIV infection To obtain preliminary evidence of antiretroviral activity of 935U83 To prospectively evaluate the emergence of in vitro drug resistance To determine the effects of 935U83 dosing on CD4 cell counts
Detailed Description:
Patients 10 per dose level are randomized to receive 1 of 4 doses of 935U83 every 8 hours for 12 weeks Five patients at each dose level must complete 4 weeks of treatment without serious toxicity before subsequent patients are entered at the next higher dose If lack of antiretroviral effect or unacceptable toxicity is demonstrated at a particular dose level the dose regimens may be adjusted
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 |
|---|---|---|---|
| 02 | None | None | None |