Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000952
Status:
COMPLETED
Last Update Posted:
2021-10-29
First Post:
1999-11-02
Brief Title:
A Study of Ritonavir an Anti-HIV Drug in HIV-Positive Infants and Children
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 Study of Ritonavir Therapy in HIV-1 Infected Infants and Children
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 study examines the safety and effectiveness of ritonavir an anti-HIV drug alone and in combination with other anti-HIV drugs in HIV-positive children under 2 years of age This study will also determine the most effective doses of ritonavir for future pediatric HIV studies
Infants infected with HIV by their mothers experience faster disease progression than adults or older children Treatment with anti-HIV drugs administered at an early age may slow disease progression in infant populations
Infants infected with HIV by their mothers experience faster disease progression than adults or older children Treatment with anti-HIV drugs administered at an early age may slow disease progression in infant populations
Detailed Description:
As a group vertically infected children experience more rapid disease progression than children infected at an older age or adults The early administration of potent antiretroviral regimens might significantly impact the course of vertical HIV-1 infection
Infants and children are stratified by age representative of the developmental differences related to drug metabolism Group I at least 6 months - 2 years Group II 3-6 months Group IIIA 1 month - 10 weeks IIIB 1 month - less than 3 months Within each age group there will be two possible dosage cohorts All age groups will be enrolled simultaneously into dosage Cohort I at the initial drug dosage Progression to Cohort II at a higher or lower drug dosage will be decided according to safety tolerance or viral load in Cohort I All therapy for Group III whether in Cohort I or II will be introduced as follows single dose of ritonavir on Day 0 ritonavir monotherapy through Day 7 AM and combination therapy from Day 7 PM through Week 104 All therapy for Group IIIA IIIB whether in Cohort I or II will be introduced as follows single dose of ritonavir on Day 0 AM and transition to combination therapy Day 0 PM through Week 104 NOTE Progression to combination therapy for Group IIIA infants is dependent upon the results of the single-dose ritonavir pharmacokinetics PK If the patient is no longer at least presumed to be HIV-infected heshe will be discontinued from the study Replacement infants who will not receive the single dose of ritonavir will be acquired from Group IIIB infants new infants that are either presumed HIV infected or have already been shown to be HIV-infected Clinical evaluations are conducted and blood and urine samples collected regularly during the treatment period in order to quantify HIV-1 levels and determine body chemistries Pharmacokinetic studies require additional blood sampling up to Week 16 AS PER AMENDMENT 63098 Pharmacokinetics data from Cohort I showed that the proposed Cohort II starting dose was too low The dose for Cohort II is now increased All subjects in Groups I II and III will begin combination therapy on Day 0 at the increased dose AS PER AMENDMENT 31300 The study has been extended for an additional 104 weeks provided the patients viral load is undetectable below 400 copiesml at the end of the initial study period While on the treatment extension patients must continue their current schedule for study drug administration and completion of study visits
Infants and children are stratified by age representative of the developmental differences related to drug metabolism Group I at least 6 months - 2 years Group II 3-6 months Group IIIA 1 month - 10 weeks IIIB 1 month - less than 3 months Within each age group there will be two possible dosage cohorts All age groups will be enrolled simultaneously into dosage Cohort I at the initial drug dosage Progression to Cohort II at a higher or lower drug dosage will be decided according to safety tolerance or viral load in Cohort I All therapy for Group III whether in Cohort I or II will be introduced as follows single dose of ritonavir on Day 0 ritonavir monotherapy through Day 7 AM and combination therapy from Day 7 PM through Week 104 All therapy for Group IIIA IIIB whether in Cohort I or II will be introduced as follows single dose of ritonavir on Day 0 AM and transition to combination therapy Day 0 PM through Week 104 NOTE Progression to combination therapy for Group IIIA infants is dependent upon the results of the single-dose ritonavir pharmacokinetics PK If the patient is no longer at least presumed to be HIV-infected heshe will be discontinued from the study Replacement infants who will not receive the single dose of ritonavir will be acquired from Group IIIB infants new infants that are either presumed HIV infected or have already been shown to be HIV-infected Clinical evaluations are conducted and blood and urine samples collected regularly during the treatment period in order to quantify HIV-1 levels and determine body chemistries Pharmacokinetic studies require additional blood sampling up to Week 16 AS PER AMENDMENT 63098 Pharmacokinetics data from Cohort I showed that the proposed Cohort II starting dose was too low The dose for Cohort II is now increased All subjects in Groups I II and III will begin combination therapy on Day 0 at the increased dose AS PER AMENDMENT 31300 The study has been extended for an additional 104 weeks provided the patients viral load is undetectable below 400 copiesml at the end of the initial study period While on the treatment extension patients must continue their current schedule for study drug administration and completion of study visits
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 345 | Registry Identifier | DAIDS ES | None |
| 10602 | REGISTRY | None | None |