Abstract

The first purpose of the study is to look at the effect of giving 3 and 4 study drugs together on the amount of HIV virus in children's blood. The combination of 3 drugs is zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP). The combination of 4 drugs is zidovudine (ZDV), lamivudine (3TC), nevirapine (NVP), and 1592U89. The goal is to see if subjects will have an undetectable amount of HIV virus in the blood by week 12. A second purpose is to see how long after week 12 the amount of virus in the blood remains undetectable. A third purpose is to determine the safety of giving the 3- and 4- drug combinations. Zidovudine and lamivudine are approved by the FDA for use in children. Nevirapine has been studied inn about 475 children, but has not yet been approved by the FDA. 1592U89 has been studied in 21 children and it has not yet been approved. The 3-drug combination (zidovudine,lamivudine and nevirapine) has never been studied together in children. The 4-drug combination (zidovudine,lamivudine, nevirapine, and 1592U89) has never been studied together in children.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000533-30
Application #
6278446
Study Section
Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
30
Fiscal Year
1998
Total Cost
Indirect Cost

  Institution

Name
Boston University
Department
Type
DUNS #
604483045
City
Boston
State
MA
Country
United States
Zip Code
02118

  Publications

Christensen, Kurt D; Uhlmann, Wendy R; Roberts, J Scott et al. (2018) A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med 20:132-141
Kattan, Meyer; Bacharier, Leonard B; O'Connor, George T et al. (2018) Spirometry and Impulse Oscillometry in Preschool Children: Acceptability and Relationship to Maternal Smoking in Pregnancy. J Allergy Clin Immunol Pract 6:1596-1603.e6
Rhee, Rennie L; Davis, John C; Ding, Linna et al. (2018) The Utility of Urinalysis in Determining the Risk of Renal Relapse in ANCA-Associated Vasculitis. Clin J Am Soc Nephrol 13:251-257
Liebschutz, Jane M; Buchanan-Howland, Kathryn; Chen, Clara A et al. (2018) Childhood Trauma Questionnaire (CTQ) correlations with prospective violence assessment in a longitudinal cohort. Psychol Assess 30:841-845
Guan, Yue; Roter, Debra L; Wolff, Jennifer L et al. (2018) The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns 101:817-823
Altman, Matthew C; Whalen, Elizabeth; Togias, Alkis et al. (2018) Allergen-induced activation of natural killer cells represents an early-life immune response in the development of allergic asthma. J Allergy Clin Immunol 142:1856-1866
Berti, Alvise; Warner, Roscoe; Johnson, Kent et al. (2018) Brief Report: Circulating Cytokine Profiles and Antineutrophil Cytoplasmic Antibody Specificity in Patients With Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol 70:1114-1121
Wallace, Zachary S; Miloslavsky, Eli M; Cascino, Matthew et al. (2017) Effect of Disease Activity, Glucocorticoid Exposure, and Rituximab on Body Composition During Induction Treatment of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Care Res (Hoboken) 69:1004-1010
Gern, James E; Calatroni, Agustin; Jaffee, Katy F et al. (2017) Patterns of immune development in urban preschoolers with recurrent wheeze and/or atopy. J Allergy Clin Immunol 140:836-844.e7
Guan, Yue; Roter, Debra L; Erby, Lori H et al. (2017) Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns 100:927-935

Showing the most recent 10 out of 476 publications