Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002324
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Nevirapine and Zidovudine Given Separately and Together in HIV-1 Infected Patients Who Have No Symptoms of the Disease
Sponsor:
Boehringer Ingelheim
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multi-Center Placebo-Controlled Double-Blind Randomized Trial Comparing the Activity Safety and Tolerance of 1 400 Mg Nevirapine in Combination With 500-600 Mg Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 3-24 Months of Prior Zidovudine Therapy and 200-500 CD4 Cellsmm3 and 2 400 Mg Nevirapine Versus Nevirapine Placebo in Asymptomatic HIV-1 Nucleoside Naive Patients With 200-500 CD4 Cellsmm3
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:
PRIMARY To compare the effect of nevirapine versus placebo alone or in combination with zidovudine AZT on CD4 T-cell count and percentage after 3 and 6 months of treatment To evaluate the safety and tolerance of nevirapine alone or in combination with AZT
SECONDARY To compare the effects of the various treatment combinations on virologic and immunologic markers
SECONDARY To compare the effects of the various treatment combinations on virologic and immunologic markers
Detailed Description:
In Part I patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT In Part II patients who are nucleoside naive receive either nevirapine or matching placebo After 6 months patients receive open-label nevirapine
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 |
|---|---|---|---|
| 1038 | None | None | None |