Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001108
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
1999-11-02
Brief Title:
A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs Some at Higher Than Usual Doses
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Multi-Drug Antiretroviral Therapy for Heavily Pretreated Pediatric AIDS Patients A Phase I Proof of Concept Trial
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 see if 7 drugs some of them given at higher doses than normal are safe and tolerated by young patients with AIDS who have failed to respond to other treatments The study will also see what effect taking several anti-HIV drugs together at high doses has on the bodys ability to fight HIV infection The 7 drugs that will be given in this study are stavudine d4T didanosine ddI lamivudine 3TC nelfinavir NFV ritonavir RTV saquinavir SQV and nevirapine NVP
This study has been changed from an 8-drug regimen to a 7-drug regimen Patients no longer receive the drug hydroxyurea HU Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs Some doctors believe anti-HIV drugs fail because drug levels in the body are too low In this study doctors will give patients 7 drugs some at higher doses than normal Since it is very important that patients on the study take all of these drugs doctors will make it as easy as possible Doctors want to try this because children with advanced AIDS have few treatment choices
This study has been changed from an 8-drug regimen to a 7-drug regimen Patients no longer receive the drug hydroxyurea HU Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs Some doctors believe anti-HIV drugs fail because drug levels in the body are too low In this study doctors will give patients 7 drugs some at higher doses than normal Since it is very important that patients on the study take all of these drugs doctors will make it as easy as possible Doctors want to try this because children with advanced AIDS have few treatment choices
Detailed Description:
Clinicians are increasingly confronted with HIV-positive children who have failed all available antiretroviral therapies and have few viable treatment options Virologic failure in these patients may be a result of antiretroviral resistance likely a result of poor adherence to the treatment regimen or inadequate dosing This study is designed to achieve adherence through observation of drug administration for the first 8 weeks of the study and to further overcome resistance by intensive high-dose multi-drug therapy Treatment with more than 4 drugs has not been studied formally in children but pediatricians caring for children with AIDS have used such strategies off study with success Dose intensification may also aid in overcoming resistance therefore in this trial d4T 3TC and NFV are administered at up to twice their standard doses Given the limited therapeutic options available to HIV-positive children with poor prognoses high-dose multi-drug therapy merits study AS PER AMENDMENT 010700 Pancreatitis which may be fatal in some cases has occurred during therapy with ddI The risk of pancreatitis may be increased when ddI is used in combination with HU ACTG A5025 a study that had a d4TddIHU arm was terminated because of significant toxicity concerns related to the HU-containing arm Patients enrolled in ACTG P1007 may be at increased risk of developing pancreatitis given their advanced disease state and the use of multiple drugs including HU The study had been amended to address these concerns AS PER AMENDMENT 121901 HU has been removed from the drug regimen
Patient enrollment is staged to allow study physicians to aggressively monitor patients for signs of toxicity Initially patients are admitted to a hospital or clinical research center for 2 weeks where they initiate an AS PER AMENDMENT 121901 8-drug regimen is replaced by 7-drug regimen and undergo frequent physical exams and blood tests to assess AS PER AMENDMENT 121901 glucose levels pharmacokinetics virologic response and toxicity If investigators identify important drug interactions requiring modification of the combination regimen or if there are early regimen-terminating toxicities the trial will be halted to address these concerns After 2 weeks the patient is discharged to return home Study personnel visit the patients house twice a day for 6 more weeks to observe drug administration and the patient continues to receive regular physical exams and blood tests At the end of Week 24 all patients with plasma RNA levels of 10000 copiesml or less are offered the opportunity to continue their regimen to Week 48 Patients with plasma RNA levels above 10000 copiesml at Week 24 and patients who experience virologic rebound at or after Week 24 are taken off study unless the patients family and the investigator feel it is in the best interest of the child to remain on study AS PER AMENDMENT 121901 The 2-week hospital or GCRC stay is no longer required A 2-day stay in a hospital or GCRC for the purpose of drug regimen training is recommended but not mandatory Study personnel visit the patient once a day for 6 weeks at an agreed upon location or by phone contact
Patient enrollment is staged to allow study physicians to aggressively monitor patients for signs of toxicity Initially patients are admitted to a hospital or clinical research center for 2 weeks where they initiate an AS PER AMENDMENT 121901 8-drug regimen is replaced by 7-drug regimen and undergo frequent physical exams and blood tests to assess AS PER AMENDMENT 121901 glucose levels pharmacokinetics virologic response and toxicity If investigators identify important drug interactions requiring modification of the combination regimen or if there are early regimen-terminating toxicities the trial will be halted to address these concerns After 2 weeks the patient is discharged to return home Study personnel visit the patients house twice a day for 6 more weeks to observe drug administration and the patient continues to receive regular physical exams and blood tests At the end of Week 24 all patients with plasma RNA levels of 10000 copiesml or less are offered the opportunity to continue their regimen to Week 48 Patients with plasma RNA levels above 10000 copiesml at Week 24 and patients who experience virologic rebound at or after Week 24 are taken off study unless the patients family and the investigator feel it is in the best interest of the child to remain on study AS PER AMENDMENT 121901 The 2-week hospital or GCRC stay is no longer required A 2-day stay in a hospital or GCRC for the purpose of drug regimen training is recommended but not mandatory Study personnel visit the patient once a day for 6 weeks at an agreed upon location or by phone contact
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 |
|---|---|---|---|
| PACTG P1007 | Registry Identifier | DAIDS ES | None |
| 11643 | REGISTRY | None | None |
| ACTG P1007 | None | None | None |