Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002387
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz
Sponsor:
Merck Sharp Dohme LLC
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
A Multicenter Open Randomized Forty-Eight-Week Pilot Study to Evaluate the Activity Safety and Pharmacokinetics of Indinavir Sulfate 1200 Mg q 12h and DMP 266 300 Mg q 12h Versus Indinavir Sulfate 1000 Mg q 8h and DMP 266 600 Mg qhs
Status:
COMPLETED
Status Verified Date:
1999-06
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 estimate the differences in parameters of antiviral activity and safety between a control regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing in protease inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive HIV-1 seropositive patients
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that
1 The observed proportion of patients with serum viral RNA 400 copiesml in the experimental and control regimen will be similar and will continue to be so after 48 weeks
2 The safety profiles of the two groups will be similar judged by the incidence of serious drug-related adverse experiences and the incidence of events of specific interest eg nephrolithiasis hyperbilirubinemia nauseavomiting rash and CNS-related symptoms and will continue to be so after 48 weeks
3 The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that
1 The observed proportion of patients with serum viral RNA 400 copiesml in the experimental and control regimen will be similar and will continue to be so after 48 weeks
2 The safety profiles of the two groups will be similar judged by the incidence of serious drug-related adverse experiences and the incidence of events of specific interest eg nephrolithiasis hyperbilirubinemia nauseavomiting rash and CNS-related symptoms and will continue to be so after 48 weeks
3 The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks
Detailed Description:
It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that
1 The observed proportion of patients with serum viral RNA 400 copiesml in the experimental and control regimen will be similar and will continue to be so after 48 weeks
2 The safety profiles of the two groups will be similar judged by the incidence of serious drug-related adverse experiences and the incidence of events of specific interest eg nephrolithiasis hyperbilirubinemia nauseavomiting rash and CNS-related symptoms and will continue to be so after 48 weeks
3 The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks
Patients are randomized to one of two regimens a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266 each at different doses than in the control regimen
1 The observed proportion of patients with serum viral RNA 400 copiesml in the experimental and control regimen will be similar and will continue to be so after 48 weeks
2 The safety profiles of the two groups will be similar judged by the incidence of serious drug-related adverse experiences and the incidence of events of specific interest eg nephrolithiasis hyperbilirubinemia nauseavomiting rash and CNS-related symptoms and will continue to be so after 48 weeks
3 The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks
Patients are randomized to one of two regimens a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266 each at different doses than in the control regimen
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 |
|---|---|---|---|
| 067-00 | None | None | None |