Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000962
Status:
COMPLETED
Last Update Posted:
2008-08-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of BI-RG-587 in HIV-Infected Patients
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 Staggered Rising Dose Cohort Study Assessing Safety Tolerance and Activity of BI-RG-587 in Patients With HIV Infection CD4 Cell Count 400 Cellsmm3
Status:
COMPLETED
Status Verified Date:
1994-12
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 assess the safety and tolerance of multiple oral doses of Nevirapine BI-RG-587 To generate data on the pharmacokinetics and dose proportionality of Nevirapine with multiple dosing To characterize the pattern of virological activity in vivo Improvement in virological end points will be examined for association with dose and absorption To determine whether development of resistance is reflected in return of virological activity and if so when markers reflect this resistance To determine if improvements of immunological endpoints are detectable in the number of patients studied A compound free of the toxic effects of nucleoside chain terminators such as zidovudine AZT may have an advantage over currently available treatments for HIV infection Such a compound has further advantages if it is active against AZT-resistant isolates Nevirapine BI-RG-587 has shown in vitro inhibitory activity against HIV-1 reverse transcriptase RT The molecular mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to its binding to an RT site distinct from those for the RNA template primer the deoxynucleotide triphosphate or the RNase H catalytic site
Detailed Description:
A compound free of the toxic effects of nucleoside chain terminators such as zidovudine AZT may have an advantage over currently available treatments for HIV infection Such a compound has further advantages if it is active against AZT-resistant isolates Nevirapine BI-RG-587 has shown in vitro inhibitory activity against HIV-1 reverse transcriptase RT The molecular mechanism of the RT inhibitory effect is hypothesized to be non-competitive inhibition due to its binding to an RT site distinct from those for the RNA template primer the deoxynucleotide triphosphate or the RNase H catalytic site
This is a staggered dose escalation cohort trial which examines the safety tolerance pharmacokinetics and activity of Nevirapine BI-RG-587 in patients with HIV infection Groups of 10 patients must have completed 4 weeks of therapy without requiring dose interruption before the next dosage level can be initiated All 10 patients must be enrolled at a lower dosage level before the next dosage level can be initiated Patients discontinue antiretroviral therapy after signing informed consent 28 days prior to receipt of a first dose of Nevirapine Screening lab tests including p24 antigen and plasma viremia and CD4 cell count determination are performed 21 days prior to drug dosing in Part I Patients are notified of screening laboratory measures that exclude them from study participation Upon such notification patients have the option to resume prior antiretroviral therapy or to repeat those values in one week Part II consists of two 8-hour intensive blood sampling periods plus frequent trough value blood samplings Safety trough value blood sampling and activity assessments are performed in Part III An assessment of dose-tolerance and of activity is made in Study Week 12 in order that patients may continue Nevirapine chronic therapy for an additional 12 weeks The Final Visit in Part IV takes place on Study Week 24 to complete the trial Patients who complete 24 weeks are offered the option to continue on Nevirapine chronic therapy at the initial or an altered dose on a separate open-label protocol
This is a staggered dose escalation cohort trial which examines the safety tolerance pharmacokinetics and activity of Nevirapine BI-RG-587 in patients with HIV infection Groups of 10 patients must have completed 4 weeks of therapy without requiring dose interruption before the next dosage level can be initiated All 10 patients must be enrolled at a lower dosage level before the next dosage level can be initiated Patients discontinue antiretroviral therapy after signing informed consent 28 days prior to receipt of a first dose of Nevirapine Screening lab tests including p24 antigen and plasma viremia and CD4 cell count determination are performed 21 days prior to drug dosing in Part I Patients are notified of screening laboratory measures that exclude them from study participation Upon such notification patients have the option to resume prior antiretroviral therapy or to repeat those values in one week Part II consists of two 8-hour intensive blood sampling periods plus frequent trough value blood samplings Safety trough value blood sampling and activity assessments are performed in Part III An assessment of dose-tolerance and of activity is made in Study Week 12 in order that patients may continue Nevirapine chronic therapy for an additional 12 weeks The Final Visit in Part IV takes place on Study Week 24 to complete the trial Patients who complete 24 weeks are offered the option to continue on Nevirapine chronic therapy at the initial or an altered dose on a separate open-label protocol
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 |
|---|---|---|---|
| 00744 | None | None | None |