Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2025-12-17 @ 5:39 PM
Study NCT ID:
NCT00038480
Status:
None
Last Update Posted:
2021-11-01 00:00:00
First Post:
2002-05-31 00:00:00
Brief Title:
Safety and Effectiveness of Lopinavir/Ritonavir in HIV Infected Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases (NIAID)
Study Overview
Official Title:
A Phase I/II Study of Lopinavir/Ritonavir in HIV-1 Infected Infants Less Than 6 Months of Age
Status:
None
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:
LPV/RTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age. LPV/RTV has been approved by the FDA to treat older children and adults with HIV. Data for children under 6 months, however, have not been available. LPV/RTV has not been approved for infants less than 6 months old, and the appropriate dose for young infants is not known. Dosing guidelines are needed for young infants, most of whom are in the early stages of primary infection. This study will help identify an appropriate dose range of LPV/RTV and evaluate response to therapy in infants less than 6 months of age. The study will also evaluate whether early therapy allows normal development of the immune system.
Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. Patients will undergo a physical exam, medical history assessment, and blood collection at selected study visits. Study visits will occur every 2 weeks for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits during the second year will be every 12 weeks until the end of the study. The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects. Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant. Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant.
Infants between 14 days and 6 months of age will receive LPV/RTV in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their physicians. Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age. Patients will undergo a physical exam, medical history assessment, and blood collection at selected study visits. Study visits will occur every 2 weeks for the first 8 weeks, then every 4 weeks until the end of the first year of the study. Study visits during the second year will be every 12 weeks until the end of the study. The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects. Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant. Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant.
Detailed Description:
LPVRTV has shown significant antiviral activity and tolerability in clinical trials in adults and children over 6 months of age LPVRTV has been approved by the FDA to treat older children and adults with HIV Data for children under 6 months however have not been available LPVRTV has not been approved for infants less than 6 months old and the appropriate dose for young infants is not known Dosing guidelines are needed for young infants most of whom are in the early stages of primary infection This study will help identify an appropriate dose range of LPVRTV and evaluate response to therapy in infants less than 6 months of age The study will also evaluate whether early therapy allows normal development of the immune system
Infants between 14 days and 6 months of age will receive LPVRTV in combination with 2 nucleoside reverse transcriptase inhibitors NRTIs chosen by their physicians Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age Patients will undergo a physical exam medical history assessment and blood collection at selected study visits Study visits will occur every 2 weeks for the first 8 weeks then every 4 weeks until the end of the first year of the study Study visits during the second year will be every 12 weeks until the end of the study The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant
Infants between 14 days and 6 months of age will receive LPVRTV in combination with 2 nucleoside reverse transcriptase inhibitors NRTIs chosen by their physicians Twelve-hour pharmacokinetic sampling is performed on Day 14 of drug treatment and when the patient reaches 12 months of age Patients will undergo a physical exam medical history assessment and blood collection at selected study visits Study visits will occur every 2 weeks for the first 8 weeks then every 4 weeks until the end of the first year of the study Study visits during the second year will be every 12 weeks until the end of the study The parent or guardian will be contacted by phone every 6 weeks to monitor adverse drug effects Participants between the ages of 6 weeks but less than 6 months old will be followed for 96 weeks after the enrollment of the last participant Participants between the ages of 14 weeks but less than 6 weeks will be followed for 48 weeks after the enrollment of the last participant
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 P1030 | Registry Identifier | DAIDS ES | None |
| 10041 | REGISTRY | None | None |