Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000747
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
An Open-Label Pilot Study to Evaluate the Development of Resistance to Nevirapine BI-RG-587 in HIV-Infected Patients With CD4 Cell Count 500mm3
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Pilot Study to Evaluate the Development of Resistance to Nevirapine BI-RG-587 in HIV-Infected Patients With CD4 Cell Count 500mm3
Status:
COMPLETED
Status Verified Date:
2011-02
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 evaluate the rate of development of resistance to nevirapine in HIV-1 infected individuals To evaluate safety of nevirapine in HIV-1 infected individuals with CD4 counts greater than or equal to 500 cellsmm3
Secondary To evaluate the effect of nevirapine on surrogate markers The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts 400 cellsmm3 In persons with less advanced HIV disease and less viral burden the emergence of resistance may be delayed thus permitting evaluation for beneficial effect in a population where there is currently no established therapy
Secondary To evaluate the effect of nevirapine on surrogate markers The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts 400 cellsmm3 In persons with less advanced HIV disease and less viral burden the emergence of resistance may be delayed thus permitting evaluation for beneficial effect in a population where there is currently no established therapy
Detailed Description:
The anti-HIV agent nevirapine is associated with rapid emergence of resistance when administered alone or in combination with zidovudine to HIV-infected patients with CD4 counts 400 cellsmm3 In persons with less advanced HIV disease and less viral burden the emergence of resistance may be delayed thus permitting evaluation for beneficial effect in a population where there is currently no established therapy
Ten patients receive nevirapine daily for 12 weeks After 12 weeks of therapy patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks Clinical and immunological assessments are performed at weeks 4 8 12 16 20 and 24 Virological assessments are performed at week 24 only If 50 percent of patients develop resistance at any time the study is discontinued
Ten patients receive nevirapine daily for 12 weeks After 12 weeks of therapy patients in whom resistance was not evident at week 4 and who have an adequate safety profile continue receiving nevirapine for an additional 12 weeks Clinical and immunological assessments are performed at weeks 4 8 12 16 20 and 24 Virological assessments are performed at week 24 only If 50 percent of patients develop resistance at any time the study is discontinued
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 |
|---|---|---|---|
| BI 00947 | None | None | None |