Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084058
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2004-06-04
Brief Title:
Safety of Saquinavir and High Doses of LopinavirRitonavir in Children With HIV
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 Safety Tolerability and Pharmacokinetic Study of High Dose LopinavirRitonavir With or Without Saquinavir in HIV-Infected Pediatric Subjects Previously Treated With Protease Inhibitors
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 effect of increased doses of lopinavirritonavir LPVr and saquinavir SQV in HIV infected children who are failing their current antiretroviral regimen
Detailed Description:
Since current drugs cannot cure HIV infection lifelong therapy is required Development of drug resistance is common with 30 to 80 of patients with initial viral load decreases following a potent anti-HIV regimen experiencing regimen failure within the first year of therapy Dose intensification increasing dosing of treatment medications has been used successfully in pediatric oncology Dose intensification in HIV infected patients may overcome resistance and as similarly observed in cancer may result in a greater rate of viral inhibition maximizing the degree and durability of viral suppression This study will evaluate dose intensification in HIV infected children and adolescents who are failing their current antiretroviral regimen and have significant genotypic and phenotypic resistance
Participants in this 3-step study will have previously undergone genotypic resistance testing as part of their regular clinical care Participants will have phenotypic resistance testing done at screening or within 6 months prior to study entry Participants in this study will have either a genotypic profile with at least 4 of the required protease mutations or phenotypic resistance to LPV that is at least fivefold greater than wild type while on a failing regimen within 6 months of study screening
In Step 1 Group 1 participants will be randomly assigned to either a drug regimen without a nonnucleoside reverse transcriptase inhibitor NNRTI or a drug regimen with an NNRTI for Group 2 participants Participants and their doctors will work with study investigators to select the best treatment regimen possible All participants in the study will receive LPVr as part of their drug regimens Participants in Group 1 will take a higher dose of LPVr than participants in Group 2 because NNRTIs lower LPVr levels in the blood
At Week 2 participants will undergo a 12-hour pharmacokinetic PK test to evaluate the drug levels in their blood If LPVr levels are not high enough to control HIV and the participant can swallow tablets hard gel capsules or the contents of hard gel capsules with food or milk the participant will begin taking SQV as part of his or her drug regimen and enter Step 2 After two weeks of taking SQV participants will again undergo PK testing at Week 6 Based on these test results the dose of SQV will then be increased decreased or maintained Participants who do not add SQV to their regimen will continue taking LPVr for the remainder of the study and stay in Step 1 If the PK test indicates SQV blood concentrations are sufficient the participant will remain in Step 2 If the PK test indicates SQV blood concentrations are too low the SQV dose will be increased and the participant will enter Step 3 After 2 weeks of taking elevated doses of SQV participants will undergo PK testing at Week 10 If the PK test indicates that SQV blood concentrations are too high the SQV dose will be decreased At Week 14 participants who receive a reduced SQV dose will again undergo PK testing to verify that SQV blood concentrations are optimal
Participants will have study visits at Weeks 2 4 6 7 and 8 then every 4 weeks through the end of the study at Week 48 Study visits will include a physical exam health history assessment and blood collection Blood collection for PK studies will occur at selected visits Study visits at Weeks 2 and 12 will include an electrocardiogram ECG or EKG
Participants in this 3-step study will have previously undergone genotypic resistance testing as part of their regular clinical care Participants will have phenotypic resistance testing done at screening or within 6 months prior to study entry Participants in this study will have either a genotypic profile with at least 4 of the required protease mutations or phenotypic resistance to LPV that is at least fivefold greater than wild type while on a failing regimen within 6 months of study screening
In Step 1 Group 1 participants will be randomly assigned to either a drug regimen without a nonnucleoside reverse transcriptase inhibitor NNRTI or a drug regimen with an NNRTI for Group 2 participants Participants and their doctors will work with study investigators to select the best treatment regimen possible All participants in the study will receive LPVr as part of their drug regimens Participants in Group 1 will take a higher dose of LPVr than participants in Group 2 because NNRTIs lower LPVr levels in the blood
At Week 2 participants will undergo a 12-hour pharmacokinetic PK test to evaluate the drug levels in their blood If LPVr levels are not high enough to control HIV and the participant can swallow tablets hard gel capsules or the contents of hard gel capsules with food or milk the participant will begin taking SQV as part of his or her drug regimen and enter Step 2 After two weeks of taking SQV participants will again undergo PK testing at Week 6 Based on these test results the dose of SQV will then be increased decreased or maintained Participants who do not add SQV to their regimen will continue taking LPVr for the remainder of the study and stay in Step 1 If the PK test indicates SQV blood concentrations are sufficient the participant will remain in Step 2 If the PK test indicates SQV blood concentrations are too low the SQV dose will be increased and the participant will enter Step 3 After 2 weeks of taking elevated doses of SQV participants will undergo PK testing at Week 10 If the PK test indicates that SQV blood concentrations are too high the SQV dose will be decreased At Week 14 participants who receive a reduced SQV dose will again undergo PK testing to verify that SQV blood concentrations are optimal
Participants will have study visits at Weeks 2 4 6 7 and 8 then every 4 weeks through the end of the study at Week 48 Study visits will include a physical exam health history assessment and blood collection Blood collection for PK studies will occur at selected visits Study visits at Weeks 2 and 12 will include an electrocardiogram ECG or EKG
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 |
|---|---|---|---|
| PACTG P1038 | Registry Identifier | DAIDS ES | None |
| 10045 | REGISTRY | None | None |