A Comparison of Two Anti-HIV Drug Regimens for Youth Who Have Failed Prior Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00102206
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 95% CI for change in BMD (both percent change in BMD and change in z-score from baseline) for each treatment group 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
- Secondary Outcome Measures
Name Time Method HIV-1 RNA growth and development markers toxicity pharmacokinetics adherence special virologic and immunologic parameters
Trial Locations
- Locations (4)
Columbia IMPAACT CRS
🇺🇸New York, New York, United States
Chicago Children's CRS
🇺🇸Chicago, Illinois, United States
SUNY Stony Brook NICHD CRS
🇺🇸Stony Brook, New York, United States
DUMC Ped. CRS
🇺🇸Durham, North Carolina, United States