Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075907
Status:
COMPLETED
Last Update Posted:
2013-10-07
First Post:
2004-01-09
Brief Title:
Anti-HIV Drug Regimens With or Without Protease Inhibitors and Drug Level Monitoring in HIV Infected Adolescents
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Comparative Trial of Protease-Containing and Protease-Sparing HAART Regimens in HIV-Infected Adolescents With an Evaluation of Therapeutic Drug Monitoring
Status:
COMPLETED
Status Verified Date:
2013-10
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 compare the effectiveness of anti-HIV drug regimens with or without a protease inhibitor PI in HIV infected adolescents It will also determine if monitoring drug levels and adjusting the dose as necessary improves the effectiveness of these regimens
Detailed Description:
HIV infected adolescents may have a significantly higher capacity for immune reconstitution following highly active antiretroviral therapy HAART compared to adults Despite this advantage HIV infected adolescents are often reluctant to get proper medical care follow through with doctor appointments and adhere to medication schedules and regimens necessary to keep their infection under control Lopinavirritonavir LPVr a PI and efavirenz EFV a non-nucleoside reverse transcriptase inhibitor NNRTI both have long half-lives that make them ideal drugs for the adolescent population as they are more forgiving if patients miss or sleep through doses The availability of once-daily dosing of LPVr will reduce pill burden and offers more flexibility in medication scheduling also helping to promote treatment adherence among this age group This study will examine the effectiveness of two HAART regimens one with the PI LPVr and two nucleoside reverse transcriptase inhibitors NRTIs and the other with the NNRTI EFV and two NRTIs The efficacy of therapeutic drug monitoring TDM and subsequent dose adjustment will also be assessed with both regimens
Patients will be enrolled in this study for 96 weeks and will be randomly assigned into one of two groups Group 1 will receive LPVr and 2 NRTIs Treatment naive patients in Group 1 will have the option of receiving either once-daily dosing or twice-daily dosing of LPVr Treatment experienced patients will receive twice-daily dosing of LPVr Patients on once-daily dosing of LPVr who become intolerant to the regimen will be permitted to switch to twice-daily dosing Group 2 will receive EFV and 2 NRTIs All patients will be independently and simultaneously randomly assigned to undergo either TDM with subsequent dose adjustment if necessary or no TDM
Patient medical history and physical exam will be conducted at screening entry Weeks 2 4 8 every 8 weeks until Week 48 and every 12 weeks thereafter Blood collection will occur at all study visits Self-reported pill counts and MEMS TrackCap readings on LPVr and EFV bottles will be noted at most visits Patients will be asked to complete adherence questionnaires at selected study visits
Patients enrolled in PACTG 390 Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger are encouraged to coenroll simultaneously in this study and in PACTG 219C Long-Term Effects of HIV Exposure and Infection in Children
Patients will be enrolled in this study for 96 weeks and will be randomly assigned into one of two groups Group 1 will receive LPVr and 2 NRTIs Treatment naive patients in Group 1 will have the option of receiving either once-daily dosing or twice-daily dosing of LPVr Treatment experienced patients will receive twice-daily dosing of LPVr Patients on once-daily dosing of LPVr who become intolerant to the regimen will be permitted to switch to twice-daily dosing Group 2 will receive EFV and 2 NRTIs All patients will be independently and simultaneously randomly assigned to undergo either TDM with subsequent dose adjustment if necessary or no TDM
Patient medical history and physical exam will be conducted at screening entry Weeks 2 4 8 every 8 weeks until Week 48 and every 12 weeks thereafter Blood collection will occur at all study visits Self-reported pill counts and MEMS TrackCap readings on LPVr and EFV bottles will be noted at most visits Patients will be asked to complete adherence questionnaires at selected study visits
Patients enrolled in PACTG 390 Different Combination Regimens and Treatment-Switching Guidelines in HIV Infected Children 18 Years of Age and Younger are encouraged to coenroll simultaneously in this study and in PACTG 219C Long-Term Effects of HIV Exposure and Infection in Children
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 |
|---|---|---|---|
| DAIDS-ES ID 10043 | None | None | None |