Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001133
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2000-01-17
Brief Title:
Safety and Tolerance of Indinavir Plus Ritonavir in HIV-Positive Patients Failing Therapy With Amprenavir Nelfinavir or Saquinavir
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase III Randomized Open-Label Study of the Safety and Pharmacokinetics of Indinavir Ritonavir Therapy in HIV-Infected Subjects Failing Amprenavir Nelfinavir Saquinavir or NelfinavirSaquinavir Combination Therapy
Status:
COMPLETED
Status Verified Date:
2021-10
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:
In this study the protease inhibitors indinavir IDV and ritonavir RTV will be studied in patients who have high levels of virus while taking other protease inhibitors The purpose of this study is to see how the body takes in distributes and gets rid of IDV and RTV This study will also look at any side effects that IDV or RTV causes
IDV is an effective anti-HIV drug but it can be difficult for patients to take For IDV to work against HIV it must be taken 3 times a day at a high dose and with a certain diet Doctors believe IDV may be easier to take if it is given with RTV Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose This study will gather information about the safety and side effects of using IDV and RTV together
IDV is an effective anti-HIV drug but it can be difficult for patients to take For IDV to work against HIV it must be taken 3 times a day at a high dose and with a certain diet Doctors believe IDV may be easier to take if it is given with RTV Patients who take IDV and RTV together may be able to take IDV only twice a day and at a lower dose This study will gather information about the safety and side effects of using IDV and RTV together
Detailed Description:
IDV a protease inhibitor has shown excellent clinical and virologic responses when combined with 2 nucleoside analogues Although effective the pharmacokinetics of IDV make it difficult to use in many patients The drug has a short half-life and requires administration in high doses every 8 hours with significant dietary restrictions Research has shown that IDV kinetics can be improved significantly by the addition of RTV allowing for administration of IDV at lower doses every 12 hours The half-life of IDV is prolonged 3- to 5-fold when administered with RTV Based on these results it is reasonable to study this combination as a twice-daily dosing regimen
Patients are randomized to receive 1 of 2 doses of IDVRTV for 24 weeks Arms A and B All patients also receive 2 nucleoside reverse transcriptase inhibitors NRTIs The NRTIs are not provided by the study Clinical assessments take place at Weeks 1 2 4 8 12 16 20 and 24 which includes a virology assessment AS PER AMENDMENT 42100 Patients who experience a confirmed virologic failure defined in protocol and elect to remain on study treatment are followed through Week 24 Patients who experience a confirmed virologic failure and elect to discontinue study treatment will have a final evaluation at the time of treatment discontinuation Patients are hospitalized for 12 hours at the Week 2 study visit for an intensive pharmacokinetic analysis
Patients are randomized to receive 1 of 2 doses of IDVRTV for 24 weeks Arms A and B All patients also receive 2 nucleoside reverse transcriptase inhibitors NRTIs The NRTIs are not provided by the study Clinical assessments take place at Weeks 1 2 4 8 12 16 20 and 24 which includes a virology assessment AS PER AMENDMENT 42100 Patients who experience a confirmed virologic failure defined in protocol and elect to remain on study treatment are followed through Week 24 Patients who experience a confirmed virologic failure and elect to discontinue study treatment will have a final evaluation at the time of treatment discontinuation Patients are hospitalized for 12 hours at the Week 2 study visit for an intensive pharmacokinetic analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5055 | Registry Identifier | DAIDS ES | None |
| 10672 | REGISTRY | None | None |
| ACTG A5055 | None | None | None |