Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000649
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
1999-11-02
Brief Title:
An Open-Label Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics Safety and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection CD4 Cell Count 400mm3
Sponsor:
Boehringer Ingelheim
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Staggered Rising Dose Cohort Study Assessing the Pharmacokinetics Safety and Tolerance of BI-RG-587 in Combination With Zidovudine in Patients With HIV Infection CD4 Cell Count 400mm3
Status:
COMPLETED
Status Verified Date:
1993-06
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 in combination with zidovudine AZT to get information on the pharmacokinetics blood levels and dose proportionality of nevirapineAZT with multiple dosing to characterize the pattern of virological activity in vivo in humans of nevirapine in combination with AZT to determine whether development of resistance to either drug is slowed by the use of the combination
Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness In addition with long-term treatment with AZT there is evidence of virus resistance to the drug Compounds that are more effective and less toxic than those in present use would be beneficial especially if they are active against AZT-resistant viruses Nevirapine has shown in vitro test tube studies activity in inhibiting HIV replication reproduction In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication
Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness In addition with long-term treatment with AZT there is evidence of virus resistance to the drug Compounds that are more effective and less toxic than those in present use would be beneficial especially if they are active against AZT-resistant viruses Nevirapine has shown in vitro test tube studies activity in inhibiting HIV replication reproduction In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication
Detailed Description:
Drugs now used in treatment for patients with AIDS show some toxicity which limits their usefulness In addition with long-term treatment with AZT there is evidence of virus resistance to the drug Compounds that are more effective and less toxic than those in present use would be beneficial especially if they are active against AZT-resistant viruses Nevirapine has shown in vitro test tube studies activity in inhibiting HIV replication reproduction In vitro studies have shown that nevirapine and AZT work together to inhibit HIV replication
Groups of 10 patients are studied at each of three dose levels Five patients at each dose level have less than 3 months of prior AZT treatment five patients at each dose level have at least 12 months of previous AZT treatment and tolerated an AZT regimen of 600 mgday 200 mg every 8 hours At least 24 patient-weeks of treatment with the combination treatment must be completed without requiring dose interruption before the next dosage level can be started All 30 patients must be enrolled at a lower dosage level before a higher dosage level is started Patients begin treatment with AZT 14 days later patients begin treatment with nevirapine in addition to the AZT After 24 weeks patients have the option to continue long-term treatment with either nevirapine or standard treatment
Groups of 10 patients are studied at each of three dose levels Five patients at each dose level have less than 3 months of prior AZT treatment five patients at each dose level have at least 12 months of previous AZT treatment and tolerated an AZT regimen of 600 mgday 200 mg every 8 hours At least 24 patient-weeks of treatment with the combination treatment must be completed without requiring dose interruption before the next dosage level can be started All 30 patients must be enrolled at a lower dosage level before a higher dosage level is started Patients begin treatment with AZT 14 days later patients begin treatment with nevirapine in addition to the AZT After 24 weeks patients have the option to continue long-term treatment with either nevirapine or standard treatment
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 |
|---|---|---|---|
| 00834 | None | None | None |