This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor 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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR010710-10
Application #
7607899
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-03-23
Project End
2007-11-30
Budget Start
2007-03-23
Budget End
2007-11-30
Support Year
10
Fiscal Year
2007
Total Cost
$5,742
Indirect Cost
Name
State University New York Stony Brook
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
804878247
City
Stony Brook
State
NY
Country
United States
Zip Code
11794
Lima, Fabio V; Gruberg, Luis; Aslam, Usman et al. (2018) The impact of unfractionated heparin or bivalirudin on patients with stable coronary artery disease undergoing percutaneous coronary intervention. J Interv Cardiol 31:177-184
Cornelius, Talea; Birk, Jeffrey L; Edmondson, Donald et al. (2018) The joint influence of emotional reactivity and social interaction quality on cardiovascular responses to daily social interactions in working adults. J Psychosom Res 108:70-77
Edmondson, Donald; Sumner, Jennifer A; Kronish, Ian M et al. (2018) The Association of Posttraumatic Stress Disorder With Clinic and Ambulatory Blood Pressure in Healthy Adults. Psychosom Med 80:55-61
Parisette-Sparks, Alyssa; Bufferd, Sara J; Klein, Daniel N (2017) Parental Predictors of Children's Shame and Guilt at Age 6 in a Multimethod, Longitudinal Study. J Clin Child Adolesc Psychol 46:721-731
Barrios, Chelsey S; Bufferd, Sara J; Klein, Daniel N et al. (2017) The interaction between parenting and children's cortisol reactivity at age 3 predicts increases in children's internalizing and externalizing symptoms at age 6. Dev Psychopathol 29:1319-1331
Farmer, Cristan A; Epstein, Jeffery N; Findling, Robert L et al. (2017) Risperidone Added to Psychostimulant in Children with Severe Aggression and Attention-Deficit/Hyperactivity Disorder: Lack of Effect on Attention and Short-Term Memory. J Child Adolesc Psychopharmacol 27:117-124
Findling, Robert L; Townsend, Lisa; Brown, Nicole V et al. (2017) The Treatment of Severe Childhood Aggression Study: 12 Weeks of Extended, Blinded Treatment in Clinical Responders. J Child Adolesc Psychopharmacol 27:52-65
Wang, Y Claire; Shimbo, Daichi; Muntner, Paul et al. (2017) Prevalence of Masked Hypertension Among US Adults With Nonelevated Clinic Blood Pressure. Am J Epidemiol 185:194-202
Jurgens, Corrine Y; Lee, Christopher S; Riegel, Barbara (2017) Psychometric Analysis of the Heart Failure Somatic Perception Scale as a Measure of Patient Symptom Perception. J Cardiovasc Nurs 32:140-147
Gadow, Kenneth D; Brown, Nicole V; Arnold, L Eugene et al. (2016) Severely Aggressive Children Receiving Stimulant Medication Versus Stimulant and Risperidone: 12-Month Follow-Up of the TOSCA Trial. J Am Acad Child Adolesc Psychiatry 55:469-78

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