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 #
5M01RR000188-37
Application #
6421260
Study Section
Project Start
2000-12-01
Project End
2001-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
2001
Total Cost
$155,764
Indirect Cost

  Institution

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

  Publications

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
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
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
Lanzieri, T M; Leung, J; Caviness, A C et al. (2017) Long-term outcomes of children with symptomatic congenital cytomegalovirus disease. J Perinatol 37:875-880
El-Hattab, Ayman W; Zarante, Ana Maria; Almannai, Mohammed et al. (2017) Therapies for mitochondrial diseases and current clinical trials. Mol Genet Metab 122:1-9
Jin, Haoxing Douglas; Demmler-Harrison, Gail J; Coats, David K et al. (2017) Long-term Visual and Ocular Sequelae in Patients With Congenital Cytomegalovirus Infection. Pediatr Infect Dis J 36:877-882
Oh, Sam S; Du, Randal; Zeiger, Andrew M et al. (2017) Breastfeeding associated with higher lung function in African American youths with asthma. J Asthma 54:856-865

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