Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000848
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Anti-HIV Effects of Saquinavir Soft Gelatin Capsules Versus Indinavir in Patients Who Have Used Saquinavir Hard Gelatin Capsules for One Year
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
The Antiviral Effect of Switching From Hard Capsule Saquinavir SQVhc to the Soft Gelatin Capsule of Saquinavir SQVsc Versus Switching to Indinavir IDV After 1 Year of Saquinavir Use
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:
To determine in HIV-infected patients whether switching to a new soft gelatin capsule formulation of saquinavir or to indinavir following prolonged use of the original hard capsule formulation of saquinavir results in an acute decrease in plasma HIV RNA
Resistance to anti-HIV agents occurs with increasing duration of use In vitro studies have shown that cross-resistance occurs among protease inhibitors although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug
Resistance to anti-HIV agents occurs with increasing duration of use In vitro studies have shown that cross-resistance occurs among protease inhibitors although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug
Detailed Description:
Resistance to anti-HIV agents occurs with increasing duration of use In vitro studies have shown that cross-resistance occurs among protease inhibitors although no clinical trials have been conducted to examine antiretroviral activity with sequential use of protease inhibitors or to determine whether saquinavir resistance can be overcome with higher concentrations of the drug
Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir At week 8 patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24 Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8 in which case they will be crossed-over to open-label therapy with the alternative drug ie either soft gelatin capsule saquinavir or indinavir
AS PER AMENDMENT 122396 Viral RNA from weeks 16 and 24 will be assayed in batch after week 24 Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months
AS PER AMENDMENT 5797 Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy the study was closed as of March 7 1997 Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks Patients on soft gel capsule saquinavir may switch immediately to indinavir or when results of HIV RNA and CD4 cell counts are available may choose to switch to indinavir or remain on soft gel capsule saquinavir Patients receiving indinavir will continue that agent Follow-up for all patients will end on 7497
Patients who are currently receiving hard capsule saquinavir are randomized to continue receiving hard capsule saquinavir or to switch to soft gelatin capsule saquinavir or indinavir At week 8 patients receiving the hard capsule formulation will switch to open-label indinavir for weeks 8-24 Patients on the other two arms will remain on their assigned regimen for the entire 24 weeks unless they have no virologic response by week 8 in which case they will be crossed-over to open-label therapy with the alternative drug ie either soft gelatin capsule saquinavir or indinavir
AS PER AMENDMENT 122396 Viral RNA from weeks 16 and 24 will be assayed in batch after week 24 Patients who exhibit an antiviral response based on this assay will be allowed to continue their current drug assignment for a total of 12 months
AS PER AMENDMENT 5797 Based on an interim analysis performed after 72 patients had completed 8 weeks of therapy the study was closed as of March 7 1997 Patients currently enrolled may stop their participation in the trial and seek other anti-retroviral therapies or may continue on study Patients on hard capsule saquinavir who remain on study will be switched to indinavir at 8 weeks Patients on soft gel capsule saquinavir may switch immediately to indinavir or when results of HIV RNA and CD4 cell counts are available may choose to switch to indinavir or remain on soft gel capsule saquinavir Patients receiving indinavir will continue that agent Follow-up for all patients will end on 7497
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 |
|---|---|---|---|
| 11305 | REGISTRY | DAIDS ES | None |