Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002166
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
An Open-Label Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune Nevirapine in Adult and Pediatric Patients With Progressive HIV Disease
Sponsor:
Boehringer Ingelheim
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune Nevirapine in Adult and Pediatric Patients With Progressive HIV Disease
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 provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are unable to participate in another Viramune controlled clinical trial and have a compelling need for anti-HIV treatment
Detailed Description:
Eligible adult patients 13 years of age will receive treatment with Viramune once daily for 2 weeks and then twice daily Eligible pediatric patients 13 years of age will receive a lower dose of Viramune once daily for 2 weeks and then twice daily All patients will receive Viramune with or without concomitant antiretroviral therapy Patients will be evaluated at weeks 2 4 8 16 24 32 and every 8 weeks thereafter
PER AMENDMENT 013197 Enrollment closed to adult patients As of 13197 only enrolling pediatric patients
PER AMENDMENT 013197 Enrollment closed to adult patients As of 13197 only enrolling pediatric patients
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 |
|---|---|---|---|
| 1100859 | None | None | None |