Abstract

This is a Phase I/II, multicenter randomized, open label trial of a standard therapeutic regimen in current use versus experimental therapies administered over 48 weeks. At least 200 HIV-infected children ages four months to 17 years of age will be enrolled. The children will be stratified by CD4+% and by age to receive one of four treatment regimens. These treatment regimens are A: d4T/nevirapine/ritonavir, B: d4T/3TC/nelfinavir, C: d4T/nevirapine/nelfinavir or D: d4T/3TC/ nevirapine/nelfinavir for 48 weeks. The first 35 subjects per arm will be evaluated with special immunologic studies LPA and extended panel immunophenotyping. Baseline and study safety evaluations will include the monitoring of adverse experiences clinical laboratory tests, physical examinations and vital signs. An assessment of virologic efficacy will occur at the 12 week interim analysis time period. Real-time HIV-1 RNA measurements will occur at weeks 12, 24 and 36. This study will also include two substudies: ACTG 725 A Pharmacokinetic Study of BID Nelfinavir's Dosing Given to Children <30 kg and ACTG 727 An Immunology Substudy of DtaP Vaccine Given to Children 2-9 Years of Age with Negative Tetanus Antibody Titers in ACTG 377.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000188-35
Application #
6264746
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
35
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Baylor College of Medicine
Department
Type
DUNS #
074615394
City
Houston
State
TX
Country
United States
Zip Code
77030

  Publications

Hunsaker, Sanita L; Garland, Beth H; Rofey, Dana et al. (2018) A Multisite 2-Year Follow Up of Psychopathology Prevalence, Predictors, and Correlates Among Adolescents Who Did or Did Not Undergo Weight Loss Surgery. J Adolesc Health 63:142-150
Lanzieri, Tatiana M; Chung, Winnie; Leung, Jessica et al. (2018) Hearing Trajectory in Children with Congenital Cytomegalovirus Infection. Otolaryngol Head Neck Surg 158:736-744
Bollard, Catherine M; Tripic, Tamara; Cruz, Conrad Russell et al. (2018) Tumor-Specific T-Cells Engineered to Overcome Tumor Immune Evasion Induce Clinical Responses in Patients With Relapsed Hodgkin Lymphoma. J Clin Oncol 36:1128-1139
Michalsky, Marc P; Inge, Thomas H; Jenkins, Todd M et al. (2018) Cardiovascular Risk Factors After Adolescent Bariatric Surgery. Pediatrics 141:
Lau, Chantal (2018) Breastfeeding Challenges and the Preterm Mother-Infant Dyad: A Conceptual Model. Breastfeed Med 13:8-17
Wattacheril, Julia; Lavine, Joel E; Chalasani, Naga P et al. (2017) Genome-Wide Associations Related to Hepatic Histology in Nonalcoholic Fatty Liver Disease in Hispanic Boys. J Pediatr 190:100-107.e2
El-Hattab, Ayman W; Almannai, Mohammed; Scaglia, Fernando (2017) Arginine and citrulline for the treatment of MELAS syndrome. J Inborn Errors Metab Screen 5:
Lanzieri, Tatiana M; Chung, Winnie; Flores, Marily et al. (2017) Hearing Loss in Children With Asymptomatic Congenital Cytomegalovirus Infection. Pediatrics 139:
Thakur, Neeta; Barcelo, Nicolas E; Borrell, Luisa N et al. (2017) Perceived Discrimination Associated With Asthma and Related Outcomes in Minority Youth: The GALA II and SAGE II Studies. Chest 151:804-812
Gururangan, Sridharan; Reap, Elizabeth; Schmittling, Robert et al. (2017) Regulatory T cell subsets in patients with medulloblastoma at diagnosis and during standard irradiation and chemotherapy (PBTC N-11). Cancer Immunol Immunother 66:1589-1595

Showing the most recent 10 out of 459 publications