Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005000
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-03-21
Brief Title:
Treatment With Nelfinavir or Efavirenz of HIV-Infected Patients Who Have Never Received Anti-HIV Drugs
Sponsor:
Agouron Pharmaceuticals
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Randomized Open-Label Study of Nelfinavir or Efavirenz in HIV-1 Infected Antiretroviral Naive Patients
Status:
UNKNOWN
Status Verified Date:
2002-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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 compare two drugs nelfinavir NFV and efavirenz EFV used in start-up anti-HIV treatment Doctors want to see if one is better than the other in extending the time that viral load level of HIV in the blood is kept low The study will also look at the response of the immune system to each drug
Detailed Description:
Patients are randomized to initiate therapy and receive either nelfinavir NFV or efavirenz EFV in the first regimen R1 All patients also receive zidovudine AZT and lamivudine 3TC Patients are further randomized in a factorial fashion and by stratification based on HIV RNA level less than 10000 10000-100000 or greater than 100000 copiesml to be administered a single injection of a neo-antigen KLH at Week 12 24 or 48 Therapy continues until switch criteria are met either before or after Week 24 When switch criteria are met patients advance to the next regimen R2
R2 patients previously taking NFV switch to EFV those randomized to EFV switch to NFV the additional NRTIs change to stavudine d4T and didanosine ddI Therapy is continued for an additional 24 weeks
R2 patients previously taking NFV switch to EFV those randomized to EFV switch to NFV the additional NRTIs change to stavudine d4T and didanosine ddI Therapy is continued for an additional 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 |
|---|---|---|---|
| AG1343-1127 | None | None | None |