Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102206
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2005-01-25
Brief Title:
A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase II Randomized Open-Label Study to Evaluate the Safety and Effectiveness of Two Antiretroviral Therapeutic Strategies A Dual PI-Based HAART Regimen Versus a Multi-NRTI ART Regimen in ART-Experienced Children and Youth Who Have Experienced Virologic Failure
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:
HIV infected children and adolescents who have taken many anti-HIV drugs may have limited treatment options and are at high risk for progressing to AIDS The purpose of this study is to determine whether an anti-HIV treatment regimen of 2 protease inhibitors PIs and 2 nucleoside reverse transcriptase inhibitors NRTIs is more effective than a regimen of 4 NRTIs in treatment-experienced children and adolescents who have failed previous anti-HIV treatment
Detailed Description:
HIV infected children and adolescents on anti-HIV treatment regimens have traditionally had more difficulty with non-adherence and drug resistance than adults often resulting in virologic failure Additionally HIV infected children with extensive exposure to antiretrovirals ARVs are likely to have fewer therapeutic options for salvage therapy and their physicians find it difficult to choose regimens that will keep the HIV infection under control This study will compare the efficacy of three 4-drug ARV salvage regimens in treatment-experienced HIV infected children and adolescents who have experienced virologic failure
This study will last at least 96 weeks Participants will be randomly assigned to one of three groups Group 1A will receive a dual-PI based regimen of lopinavirritonavir LPVr saquinavir SQV and the NRTIs emtricitabine FTC and abacavir sulfate ABC Group 1B will receive a dual-PI based regimen of LPVr SQV FTC and tenofovir disoproxil fumarate TDF Group 2 will receive an NRTI-only regimen of ABC lamivudine zidovudine and TDF
There will be 11 study visits during Step I of this study Medical history a physical exam and blood collection will occur at all visits Dual-energy x-ray absorptiometry DEXA scans will occur at study entry and at Weeks 24 48 72 and 96 Urine collection will occur at most visits participants will also take part in adherence modules at most visits Participants will be asked to complete a pill count form at Weeks 4 and 24 Additionally some study participants will be asked to participate in an intensive pharmacokinetics study at Week 4
This study will last at least 96 weeks Participants will be randomly assigned to one of three groups Group 1A will receive a dual-PI based regimen of lopinavirritonavir LPVr saquinavir SQV and the NRTIs emtricitabine FTC and abacavir sulfate ABC Group 1B will receive a dual-PI based regimen of LPVr SQV FTC and tenofovir disoproxil fumarate TDF Group 2 will receive an NRTI-only regimen of ABC lamivudine zidovudine and TDF
There will be 11 study visits during Step I of this study Medical history a physical exam and blood collection will occur at all visits Dual-energy x-ray absorptiometry DEXA scans will occur at study entry and at Weeks 24 48 72 and 96 Urine collection will occur at most visits participants will also take part in adherence modules at most visits Participants will be asked to complete a pill count form at Weeks 4 and 24 Additionally some study participants will be asked to participate in an intensive pharmacokinetics study at Week 4
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 P1053 | Registry Identifier | DAIDS ES | None |
| 10131 | REGISTRY | None | None |