A DUAL PI-BASED HAART REGIMEN VS A MULTI-NRTI ART REGIMEN, PACTG P1053

这个子项目是众多研究子项目之一

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Anti-HIV medicines are grouped according to how they work - these groups are called classes. Doctors recommend taking a combination of three anti-HIV medicines from at least two different classes. However, we do not know what combinations of anti-HIV medicines will work best for children/adolescents who have been on many different anti-HIV medicines that are still unable to control the HIV in the blood. This study will see if a combination of four anti-HIV medicines from only one class works as well as a combination of four anti-HIV medicines from two classes. We think that a combination of four anti-HIV medicines will work better for children who have taken many anti-HIV medicines in the past. However, there may be more risks associated with taking four anti-HIV medicines. These risks are discussed more in the "What Are the Risks of This Study?" section of this consent form. We do not know if four anti-HIV medicines will work better than three. The three combinations of anti-HIV medicines used in this study are: " lopinavir/ritonavir + saquinavir + emtricitabine + abacavir (Group 1A) " lopinavir/ritonavir + saquinavir + emtricitabine + tenofovir (Group 1B) " abacavir + lamivudine + zidovudine + tenofovir (Group 2) The first two combinations include anti-HIV medicines from 2 classes, called protease inhibitors (PIs) and nucleoside reverse transcriptase inhibitors (NRTIs). The last combination includes anti-HIV medicines only from the NRTI class. Tenofovir, saquinavir, and emtricitabine are approved by the FDA for use in HIV-infected adults, but have not been approved for use in HIV-infected children. The other anti-HIV medicines are approved by the FDA for use in HIV-infected children. We will look at how well your/your child's immune system responds to these medicines. We will also look at how safe these medicines are, and how well you/your child tolerate(s) these medicines. One of the medicines - tenofovir - may decrease bone mineral density (how dense, or solid, the bones are). In some animal studies, treatment with tenofovir resulted in lower bone mineral density. Tenofovir does not appear to have much effect on bone mineral density in adults, but it may have more of an effect in children. We will compare the combinations that include tenofovir with the combinations that do not include tenofovir.