Actg 300 - Study of Zdv-3tc vs Ddi or Zdv + Ddi in HIV Positive Children

Abstract

This Phase II/III, randomized, comparative, double-blind multicenter trial is designed to determine the comparative effectiveness of 3TC+ZDV versus the better of ddI monotherapy versus ZDV+ddI combination therapy with respect to HIV disease progression. The safety and tolerance of 3TC/ZDV in ZDV naive, symptomatic children will be evaluated. The study will also further validate the correlation between quantitative plasma RNA levels and HIV disease progression in children. There have been 528 patients accrued nationwide out of a target of 740. The ZDV+ddI arm is closed to accrual, but the blinded treatment arm was continued on subjects already enrolled. A secondary study objective to compart ZDV+ddI vs the other two arms with respect to changes in RNA was added.

Funding Agency

• Agency: National Institute of Health (NIH)
• Institute: National Center for Research Resources (NCRR)
• Type: General Clinical Research Centers Program (M01)
• Project #: 5M01RR002558-13
• Application #: 2789204
• Budget Start: 1997-10-01
• Budget End: 1998-09-30
• Support Year: 13
• Fiscal Year: 1998

Institution

• Name: University of Texas Health Science Center Houston
• City: Houston
• State: TX
• Country: United States
• Zip Code: 77225

Publications

Chappell, Cynthia L; Darkoh, Charles; Shimmin, Lawrence et al. (2016) Fecal Indole as a Biomarker of Susceptibility to Cryptosporidium Infection. Infect Immun 84:2299-306

Liao, George P; Harting, Matthew T; Hetz, Robert A et al. (2015) Autologous bone marrow mononuclear cells reduce therapeutic intensity for severe traumatic brain injury in children. Pediatr Crit Care Med 16:245-55

Arroyo-Ávila, Mariangelí; Santiago-Casas, Yesenia; McGwin Jr, Gerald et al. (2015) Clinical associations of anti-Smith antibodies in PROFILE: a multi-ethnic lupus cohort. Clin Rheumatol 34:1217-23

Chappell, Cynthia L; Okhuysen, Pablo C; Langer-Curry, Rebecca C et al. (2015) Cryptosporidium muris: infectivity and illness in healthy adult volunteers. Am J Trop Med Hyg 92:50-5

Reveille, John D (2014) An update on the contribution of the MHC to AS susceptibility. Clin Rheumatol 33:749-57

Bethi, Siddharth; Dasgupta, Abhijit; Weisman, Michael H et al. (2013) Functional limitations due to axial and peripheral joint impairments in patients with ankylosing spondylitis: are focused measures more informative? Arthritis Care Res (Hoboken) 65:607-14

Ward, Michael M; Learch, Thomas J; Gensler, Lianne S et al. (2013) Regional radiographic damage and functional limitations in patients with ankylosing spondylitis: differences in early and late disease. Arthritis Care Res (Hoboken) 65:257-65

Benjamin-Garner, Ruby; Stotts, Angela (2013) Impact of smoking exposure change on infant birth weight among a cohort of women in a prenatal smoking cessation study. Nicotine Tob Res 15:685-92

Ornstein, Tisha J; Max, Jeffrey E; Schachar, Russell et al. (2013) Response inhibition in children with and without ADHD after traumatic brain injury. J Neuropsychol 7:1-11

Murthy, Vijaya; Willis, Rohan; Romay-Penabad, Zurina et al. (2013) Value of isolated IgA anti-?2 -glycoprotein I positivity in the diagnosis of the antiphospholipid syndrome. Arthritis Rheum 65:3186-93