Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007449
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2000-12-19
Brief Title:
Safety and Effectiveness of the Drug DPC 083 in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Patients Who Are Failing Treatment With Nonnucleoside Reverse Transcriptase Inhibitors
Sponsor:
Dupont Applied Biosciences
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Phase II Open Label Multicenter Study to Assess the Safety and Efficacy of 100 Mg DPC 083 Once Daily in Combination With Nucleoside Analogue Reverse Transcriptase Inhibitors in HIV-1-Infected Subjects Who Are Failing Treatment With a Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Regimen
Status:
UNKNOWN
Status Verified Date:
2002-06
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
The purpose of this study is to determine the safety and tolerability of the study drug DPC 083 combined with 2 nucleoside reverse transcriptase inhibitors NRTIs in HIV-infected patients who are failing their nonnucleoside reverse transcriptase inhibitor NNRTI treatment
In some studies DPC 083 an NNRTI has been found to lower the amount of HIV in the blood viral load where drug-resistant types of HIV were not lowered by other NNRTIs This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs
In some studies DPC 083 an NNRTI has been found to lower the amount of HIV in the blood viral load where drug-resistant types of HIV were not lowered by other NNRTIs This study will attempt to determine how safe DPC 083 is when it is taken in combination with 2 NRTIs
Detailed Description:
Preclinical and human pharmacokinetic data suggest that DPC 083 can be administered once daily and provide trough plasma concentrations of free drug that will suppress replication of HIV-1 including strains containing key resistance mutations observed after failure of treatment with currently available NNRTIs This study will provide an assessment of safety and a preliminary assessment of the efficacy of DPC 083 when administered at a dose of 100 mg once daily in combination with 2 NRTIs in a population of HIV-1-infected patients who are failing treatment with an NNRTI-containing regimen
Patients receive DPC 083 once daily in combination with 2 NRTIs The 2 NRTIs are selected by the investigators based on HIV-1 genotyping results Analyses for patient safety and drug efficacy are done at Weeks 8 24 and 48 using results from clinical laboratory tests and physical exams Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 48 weeks of treatment Patients return for post-therapy follow-up visits at 1 and 3 months following early termination or study completion Some patients may participate in a substudy which evaluates changes in HIV-1 levels in cerebrospinal fluid CSF
Patients receive DPC 083 once daily in combination with 2 NRTIs The 2 NRTIs are selected by the investigators based on HIV-1 genotyping results Analyses for patient safety and drug efficacy are done at Weeks 8 24 and 48 using results from clinical laboratory tests and physical exams Patients continue to receive DPC 083 and NRTIs until the last patient enrolled in the study completes 48 weeks of treatment Patients return for post-therapy follow-up visits at 1 and 3 months following early termination or study completion Some patients may participate in a substudy which evaluates changes in HIV-1 levels in cerebrospinal fluid CSF
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 |
|---|---|---|---|
| DPC 083-203 | None | None | None |