Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002323
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
A Multi-Center Placebo-Controlled Double-Blind Randomized Trial Comparing the Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 200-500 CD4 Cell
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 Virologic and Immunologic Activities of 400 Mg Nevirapine in Combination With Zidovudine Versus Zidovudine Alone in Asymptomatic HIV-1 Infected Patients With 4-12 Months of Prior Zidovudine Therapy and 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 virologic activity quantitative RNA PCR quantitative PBMC of the combination of nevirapine and zidovudine AZT versus AZT alone after 3 and 6 months of treatment To compare the effects of these two regimens on CD4 T-cell count and percentage
SECONDARY To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapineAZT versus AZT alone To compare the effects of the two regimens on clinical signs and symptoms To evaluate the safety and tolerance of the two regimens
SECONDARY To compare and evaluate other markers of immunologic and virologic activity in patients receiving nevirapineAZT versus AZT alone To compare the effects of the two regimens on clinical signs and symptoms To evaluate the safety and tolerance of the two regimens
Detailed Description:
Patients receive combination nevirapineAZT or AZT alone Patients are evaluated for virologic and immunologic activity at 3 and 6 months
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 |
|---|---|---|---|
| BIPI 1037 | None | None | None |