Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002381
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Nevirapine Plus Nelfinavir in HIV-1 Infected Patients Who Have Taken Stavudine
Sponsor:
Boehringer Ingelheim
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Investigation of the Potential Pharmacokinetic Interaction Between Nevirapine Viramune and Nelfinavir Viracept and the Efficacy of This Combination Therapy in HIV-1 Infected Adults Treated With Stavudine d4T Zerit
Status:
COMPLETED
Status Verified Date:
2002-08
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:
To determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine d4T and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir and d4T compared to the historical controls treated with nevirapine but without nelfinavir or d4T To determine the efficacy of long-term combination therapy of nevirapine nelfinavir and d4T on viral load in patients who are non-nucleoside reverse transcriptase inhibitor NNRTI and protease inhibitor naive and have 6 months prior d4T exposure at the time of screening
Detailed Description:
The trial is an open-label study in patients with HIV-1 infection who are naive to treatment with NNRTI and protease inhibitor classes of antiretroviral drugs and have 6 months prior exposure to d4T at the time of screening Part I of this trial is an investigation of potential pharmacokinetic interaction between nevirapine and nelfinavir in HIV-1-infected adults treated with d4T Part II is an investigation of the long-term antiviral activity of the combination of nevirapine and nelfinavir on viral load as measured by HIV-1 RNA
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 |
|---|---|---|---|
| 11001224 | None | None | None |