Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002368
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
Sponsor:
Boehringer Ingelheim
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An International Double Blind Randomized Phase III Study to Evaluate the Tolerance Safety and Effectiveness of Viramune Nevirapine in Preventing Clinical AIDS Progression Events or Death When Used in Combination With Lamivudine 3TC and Stable 4 Weeks Background Nucleoside Therapy
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 evaluate the tolerance safety and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy
Detailed Description:
Eligible patients will be randomized to treatment with either 1 open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily or 2 open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune Patients will start Viramune and 3TC on study day 0 Patients will be evaluated for development of AIDS progression events at months 1 2 3 and 4 and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months whichever occurs first
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 |
|---|---|---|---|
| 11001090 | None | None | None |