Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000913
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study to Compare Two Anti-HIV Combination Therapies Each Containing Saquinavir in HIV-Positive Children
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Trial of Two Saquinavir-Containing Combination Treatment Regimens in Children With HIV Infection
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:
The purpose of this study is to determine the safety and effectiveness of a soft-gel capsule formulation of saquinavir SQV-SGC a protease inhibitor when given in combination with other anti-HIV drugs
SQV-SGC has been tested in adults for the treatment of HIV infection but more information is still needed about SQV-SGC in children Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors
SQV-SGC has been tested in adults for the treatment of HIV infection but more information is still needed about SQV-SGC in children Recent studies suggest that this soft-gel capsule form may be safer and more effective than other protease inhibitors
Detailed Description:
Clinical trials in adults and children suggest that SQV-SGC has advantages over other protease inhibitors in terms of tolerability safety and effectiveness in patients who have failed therapy with other protease inhibitors AS PER AMENDMENT 112499 Pharmacokinetic data from this study demonstrate lower than expected plasma SQV exposures particularly in Arm 1 Based on these data patients in the study will be offered the opportunity to adjust their doses Ritonavir added to the Arm 1 regimen is expected to significantly increase SQV-SGC plasma levels and allow twice-daily dosing for SQV-SGC
Patients are randomized to one of two study arms Patients in Arm 1 receive SQV-SGC plus two AS PER AMENDMENT 112499 one or two NRTIs of choice Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death cancer or fetal abnormality NRTIs are not provided as part of this study AS PER AMENDMENT 112499 This study is closed to accrual All subjects on follow-up Cohort 1 are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study version 20 Those electing to continue participation constitute Cohort 1A The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs Ritonavir is not provided as part of this study The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1200 mg twice-daily to 1600 mg twice-daily Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new regimen
Patients are randomized to one of two study arms Patients in Arm 1 receive SQV-SGC plus two AS PER AMENDMENT 112499 one or two NRTIs of choice Patients in Arm 2 receive SQV-SGC plus NFV plus one or two NRTIs of choice All participants are evaluated by physical examinations and laboratory tests during the study and are followed for incidence of death cancer or fetal abnormality NRTIs are not provided as part of this study AS PER AMENDMENT 112499 This study is closed to accrual All subjects on follow-up Cohort 1 are given the option of either discontinuing participation in ACTG 397 or participating in the next phase of the study version 20 Those electing to continue participation constitute Cohort 1A The adjusted Arm 1 regimen consists of SQV-SGC plus ritonavir plus one or two NRTIs Ritonavir is not provided as part of this study The Arm 2 regimen study drugs have not changed but the maximum allowable dose of SQV-SGC has increased from 1200 mg twice-daily to 1600 mg twice-daily Participants continue to be followed with physical examinations and laboratory evaluations that include an intensive pharmacokinetics study on Day 14 of the new 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 |
|---|---|---|---|
| 11353 | REGISTRY | DAIDS ES | None |