Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000872
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
Treatment With Combinations of Several Antiviral Drugs in Infants and Young Children With HIV Infection
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Early Intensive Antiretroviral Combination 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:
This trial tests the safety and effectiveness of the early use of combinations of anti-HIV drugs in HIV-infected infants and young children in an effort to block virus growth and preserve normal immune functions
Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth
Various anti-HIV drug combinations need to be tested in order to find the best way to treat infants and children who have been infected with HIV during birth
Detailed Description:
This study examines the antiretroviral activity of ZDV3TCNVP in vertically-infected infants and children aged 15 days up to 2 years and ZDV3TCNVPABC in vertically-infected infants and children aged 30 days up to 2 years This study will assess HIV-1 and CD4CD8 T-cell kinetics activation and maturation It will also test the concept that early younger than 3 months of age use of potent combination antiretroviral therapy will allow the long-term control of viral replication with preservation of normal immune function AS PER AMENDMENT 31198 This study will also examine the antiretroviral activity of ZDV3TCNVPNFV in vertically infected infants and children
This is a 2-part Phase III open-label trial in HIV-infected infants Part A assesses the triple combination of ZDV 3TC and NVP Four to eight patients are enrolled in each age cohort Cohort 1 at least 15 days no more than 3 months Cohort 2 over 3 months no more than 2 years Part B assesses the quadruple combination of ZDV 3TC NVP and ABC Eight patients are enrolled in each age cohort Cohort 3 at least 30 days no more than 3 months Cohort 4 over 3 months no more than 2 years AS PER AMENDMENT 31198 This study is now a 3-part Phase III trial Parts A and B are as above Part C will assess the quadruple regimen of d4T 3TC NVP and NFV Up to 8 patients will be enrolled in each age cohort Cohort 5 at least 15 days no more than 3 months Cohort 6 over 3 months no more than 2 years If 3 of 4 patients in either cohort of Part B do not achieve plasma RNA less than 1000 copiesml after 16 weeks of quadruple therapy enrollment of patients to that cohort will stop and enrollment of 8 patients to the corresponding cohort in Part C will begin For Part C patients whose RNA level is no more than 1000 copiesml at Week 16 will remain on assigned treatment until Week 104 If at any time between Weeks 16 and 104 a patients RNA level increases to greater than 1000 copiesml plasma RNA will be repeated within 1 week If both RNA levels are greater than 1000 copiesml the patient will discontinue study treatment and be followed every 12 weeks for 1 year AS PER AMENDMENT 41499 The study has been extended for an additional 96 weeks for children with continued suppression of viral replication RNA less than 400 copiesml at Week 104 If at any time between Week 12 or 16 and Week 200 a patients RNA level increases to greater than 1000 copiesml plasma RNA will be repeated within 1 week If both RNA levels are above 1000 copiesml the patient will discontinue treatment for best available therapy and be followed every 12 weeks for 1 year following the discontinuation of study treatment AS PER AMENDMENT 91699 An additional cohort Cohort 7 of 5 to 10 patients has been added Cohort 7 includes patients between 15 days and 3 months of age Cohort 7 patients who experience suppression of viral replication at Week 104 are followed through Week 200
This is a 2-part Phase III open-label trial in HIV-infected infants Part A assesses the triple combination of ZDV 3TC and NVP Four to eight patients are enrolled in each age cohort Cohort 1 at least 15 days no more than 3 months Cohort 2 over 3 months no more than 2 years Part B assesses the quadruple combination of ZDV 3TC NVP and ABC Eight patients are enrolled in each age cohort Cohort 3 at least 30 days no more than 3 months Cohort 4 over 3 months no more than 2 years AS PER AMENDMENT 31198 This study is now a 3-part Phase III trial Parts A and B are as above Part C will assess the quadruple regimen of d4T 3TC NVP and NFV Up to 8 patients will be enrolled in each age cohort Cohort 5 at least 15 days no more than 3 months Cohort 6 over 3 months no more than 2 years If 3 of 4 patients in either cohort of Part B do not achieve plasma RNA less than 1000 copiesml after 16 weeks of quadruple therapy enrollment of patients to that cohort will stop and enrollment of 8 patients to the corresponding cohort in Part C will begin For Part C patients whose RNA level is no more than 1000 copiesml at Week 16 will remain on assigned treatment until Week 104 If at any time between Weeks 16 and 104 a patients RNA level increases to greater than 1000 copiesml plasma RNA will be repeated within 1 week If both RNA levels are greater than 1000 copiesml the patient will discontinue study treatment and be followed every 12 weeks for 1 year AS PER AMENDMENT 41499 The study has been extended for an additional 96 weeks for children with continued suppression of viral replication RNA less than 400 copiesml at Week 104 If at any time between Week 12 or 16 and Week 200 a patients RNA level increases to greater than 1000 copiesml plasma RNA will be repeated within 1 week If both RNA levels are above 1000 copiesml the patient will discontinue treatment for best available therapy and be followed every 12 weeks for 1 year following the discontinuation of study treatment AS PER AMENDMENT 91699 An additional cohort Cohort 7 of 5 to 10 patients has been added Cohort 7 includes patients between 15 days and 3 months of age Cohort 7 patients who experience suppression of viral replication at Week 104 are followed through Week 200
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 356 | Registry Identifier | DAIDS ES | None |
| 10605 | REGISTRY | None | None |