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A feasibility study of immediate versus deferred antiretroviral therapy in children with HIV infection

Authors :
Ubolyam Sasiwimol
Chuenyam Theshinee
Apateerapong Wichitra
Lumbiganon Pagakrong
Intasan Jintana
Pancharoen Chitsanu
Engchanil Chulapan
Kosalaraksa Pope
Siangphoe Umaporn
Ananworanich Jintanat
Bunupuradah Torsak
Lange Joep
Cooper David A
Phanuphak Praphan
Source :
AIDS Research and Therapy, Vol 5, Iss 1, p 24 (2008)
Publication Year :
2008
Publisher :
BMC, 2008.

Abstract

Abstract Objective To evaluate the feasibility of a large immediate versus deferred antiretroviral therapy (ART) study in children. Methods We conducted an open-label pilot randomized clinical trial study in 43 Thai children with CD4 15 to 24% of starting generic AZT/3TC/NVP immediately (Arm 1) or deferring until CD4 < 15% or CDC C (Arm 2). Primary endpoints were recruitment rate, adherence to randomized treatment and retention in trial. Secondary endpoints were % with CDC C or CD4 < 15%. Children were in the trial until the last child reached 108 weeks. Intention to treat and on treatment analyses were performed. Results Recruitment took 15 months. Twenty-six of 69 (37.7%) were not eligible due mainly to low CD4%. Twenty four and 19 were randomized to arms 1 and 2 respectively. All accepted the randomized arm; however, 3 in arm 1 stopped ART and 1 in arm 2 refused to start ART. Ten/19 (53%) in arm 2 started ART. At baseline, median age was 4.8 yrs, CDC A:B were 36:7, median CD4 was 19% and viral load was 4.8 log. All in arm 1 and 17/19 in arm 2 completed the study (median of 134 weeks). No one had AIDS or death. Four in immediate arm had tuberculosis. Once started on ART, deferred arm children achieved similar CD4 and viral load response as the immediate arm. Adverse events were similar between arms. The deferred arm had a 26% ART saving. Conclusion Almost 40% of children were not eligible due mainly to low CD4% but adherence to randomized treatment and retention in trial were excellent. A larger study to evaluate when to start ART is feasible.

Details

Language :
English
ISSN :
17426405
Volume :
5
Issue :
1
Database :
Directory of Open Access Journals
Journal :
AIDS Research and Therapy
Publication Type :
Academic Journal
Accession number :
edsdoj.102445c81c324c7480bf5a02ea56f055
Document Type :
article
Full Text :
https://doi.org/10.1186/1742-6405-5-24