Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002390
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Study of the Safety and Effectiveness of Different Doses of 1592U89 in HIV-Infected Patients
Sponsor:
Glaxo Wellcome
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Randomized Blinded Dose-Ranging Multicenter Study to Evaluate the Safety and Efficacy of Different Regimens of 1592U89 Monotherapy Upon Selected Immunological and Virological Markers of HIV-1 Infection in Antiretroviral Therapy-Naive Patients
Status:
COMPLETED
Status Verified Date:
1997-08
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:
The purpose of this study is to see if giving 1592U89 to HIV-infected patients is safe and effective in lowering viral load level of HIV in the blood and raising the level of CD4 cells cells of the body that help fight infection
Detailed Description:
Patients are randomized to receive one of three doses of 1592U89 During this randomized dosing phase if a patient meets one of the following criteria heshe is offered open-label 1592U89 300 mg plus zidovudine ZDV plus lamivudine 3TC or other licensed antiretrovirals according to standard practice Criteria are based on falling CD4 counts return to baseline on two occasions at least 1 month apart disease progression defined as occurrence of a new AIDS-defining event according to CDC classification excluding CD4 counts less than 200 cellsmm3 or lack of virus suppression defined as less than 07log10 reduction in viral load at Week 4 with a repeat value 1 week later more than 5000 copiesml HIV RNA at Weeks 12 16 20 or 24 or 5000 copiesml or more anytime after Week 24
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 |
|---|---|---|---|
| CNAB2002 | None | None | None |