A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
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.
Drug: Abacavir sulfate
Drug: Tenofovir disoproxil fumarate
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Tolerability of dual PI-based HAART versus multi-NRTI HAART salvage regimens (time to first intolerant event)
- 95% confidence interval (CI) for change in CD4% computed for PI-containing groups versus PI-sparing group
- 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group
- HIV-1 RNA
- growth and development markers
- special virologic and immunologic parameters
|Study Completion Date:||May 2007|
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 lopinavir/ritonavir (LPV/r), saquinavir (SQV), and the NRTIs emtricitabine (FTC) and abacavir sulfate (ABC). Group 1B will receive a dual-PI based regimen of LPV/r, 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.
|United States, Illinois|
|Chicago Children's CRS|
|Chicago, Illinois, United States, 60614|
|United States, New York|
|Columbia IMPAACT CRS|
|New York, New York, United States|
|SUNY Stony Brook NICHD CRS|
|Stony Brook, New York, United States, 11794-8111|
|United States, North Carolina|
|DUMC Ped. CRS|
|Durham, North Carolina, United States, 27710|
|Study Chair:||Andrew Wiznia, MD||Jacobi Medical Center|
|Study Chair:||Ann J. Melvin, MD, MPH||Seattle Children's Hospital and Regional Medical Center|