Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012519
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2001-03-10
Brief Title:
Ritonavir and Indinavir in Children Failing Other Anti-HIV Treatment
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 Trial of Ritonavir and Indinavir in Children Failing Other Antiretroviral 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:
Both ritonavir RTV and indinavir IDV are approved by the FDA to treat HIV but IDV has not been approved for use in children and the doses for the combination of the two drugs has not been studied in children The purpose of this study is to find a combination of RTV and IDV that is safe well tolerated and produces drug levels in the blood of children that are comparable to effective drug levels in the blood of adults The effectiveness of the drug combination in decreasing the amount of virus in the body will also be studied The children enrolled in this study will have high HIV viral loads despite taking anti-HIV drugs
Detailed Description:
Combination regimens of RTV and IDV in adults offer the benefit of two potent antiretroviral agents convenience of twice-daily dosing unrestricted timing of meals and fewer renal complications There are limited largely anecdotal data from children suggesting that initial virologic response can also be attained in children given IDV with RTV but there are not sufficient pharmacokinetic data to define appropriate dose regimens This study will evaluate the clinical feasibility of a combination RTV and IDV regimen for children
Patients will be stratified on the basis of ageTanner stage and ability to swallow intact capsules Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses The Low Dose RTV Arm will receive a dosing ratio of RTVIDV of approximately 13 Patients will have scheduled study visits every 4 weeks for 6 months then every 3 months for approximately 18 months Study visits will consist of a medical history physical exam and blood and urine tests Patients will have intensive pharmacokinetic analysis at Week 4 or 2 weeks after a stable dose of study drugs has been reached and Week 16 Study visits that include pharmacokinetic analysis will last 9 to 13 hours
At each study visit patients will be closely assessed for drug toxicity and virologic response At the end of the study patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen
Patients will be stratified on the basis of ageTanner stage and ability to swallow intact capsules Patients will be randomized to either Balanced Dose or Low Dose RTV treatment arms Patients in the Balanced Dose Arm will receive RTV and IDV in approximately equal doses The Low Dose RTV Arm will receive a dosing ratio of RTVIDV of approximately 13 Patients will have scheduled study visits every 4 weeks for 6 months then every 3 months for approximately 18 months Study visits will consist of a medical history physical exam and blood and urine tests Patients will have intensive pharmacokinetic analysis at Week 4 or 2 weeks after a stable dose of study drugs has been reached and Week 16 Study visits that include pharmacokinetic analysis will last 9 to 13 hours
At each study visit patients will be closely assessed for drug toxicity and virologic response At the end of the study patients with good virologic response and no evidence of toxicity may choose to enter a 48 week extension phase and continue taking the combination regimen
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 P1013 | Registry Identifier | DAIDS ES | None |
| 10191 | REGISTRY | None | None |
| ACTG P1013 | None | None | None |