Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001111
Status:
COMPLETED
Last Update Posted:
2011-03-01
First Post:
1999-11-02
Brief Title:
A Study of Nevirapine Used Alone or in Combination With AZT in HIV-1-Infected Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Pharmacokinetics Safety Tolerance and Activity of Nevirapine BI-RG-587 Alone and in Combination With AZT in Mildly to Moderately Symptomatic HIV-1 Infected Children
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:
Monotherapy phase To evaluate and compare the safety tolerance pharmacokinetics and preliminary activity of nevirapine administered alone in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years to evaluate and compare the safety tolerance and pharmacokinetics of nevirapine in HIV-infected children ages 1 day to less than 2 months Combination therapy phase To evaluate and compare the safety tolerance pharmacokinetics and preliminary activity of nevirapine administered in combination with zidovudine AZT in mildly to moderately symptomatic HIV-infected children ages 2 months to less than 18 years
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed Nevirapine BI-RG-587 has shown in vitro inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine AZT in a plaque reduction assay
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed Nevirapine BI-RG-587 has shown in vitro inhibitory activity against HIV-1reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine AZT in a plaque reduction assay
Detailed Description:
Compounds with reverse transcriptase inhibitory activity that are more potent and less toxic than the nucleoside analogues are needed Nevirapine BI-RG-587 has shown in vitro inhibitory activity against HIV-1 reverse transcriptase and has shown a synergistic inhibition of HIV-1 replication when combined with zidovudine AZT in a plaque reduction assay
Sixty mildly to moderately symptomatic HIV-infected children five patients in each of four age groups will receive oral nevirapine at 1 of 3 doses for 168 days If preliminary activity is demonstrated and toxicity is acceptable after 84 days of treatment in the three oldest age groups ages 2 months - less than 2 years ages 2 years - less than 13 years and ages 13 years - less than 18 years children ages 1 day - less than 2 months will receive one of the three doses of nevirapine Additionally 15 additional patients five in each of three age groups will receive zidovudine in combination with nevirapine At the end of 24 weeks of combination therapy patients discontinue zidovudine for 2 weeks while remaining on nevirapine in order for pharmacokinetic sampling to be done Children will be enrolled sequentially by decreasing age and increasing nevirapine dose
Sixty mildly to moderately symptomatic HIV-infected children five patients in each of four age groups will receive oral nevirapine at 1 of 3 doses for 168 days If preliminary activity is demonstrated and toxicity is acceptable after 84 days of treatment in the three oldest age groups ages 2 months - less than 2 years ages 2 years - less than 13 years and ages 13 years - less than 18 years children ages 1 day - less than 2 months will receive one of the three doses of nevirapine Additionally 15 additional patients five in each of three age groups will receive zidovudine in combination with nevirapine At the end of 24 weeks of combination therapy patients discontinue zidovudine for 2 weeks while remaining on nevirapine in order for pharmacokinetic sampling to be done Children will be enrolled sequentially by decreasing age and increasing nevirapine dose
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 |
|---|---|---|---|
| 882 | None | None | None |