Research

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

Jintanat Ananworanich^1,2 , Pope Kosalaraksa³ , Umaporn Siangphoe^1,2 , Chulapan Engchanil³ , Chitsanu Pancharoen⁴ , Pagakrong Lumbiganon³ , Jintana Intasan¹ , Wichitra Apateerapong^1,2 , Theshinee Chuenyam¹ , Sasiwimol Ubolyam¹ , Torsak Bunupuradah¹ , Joep Lange^1,5 , David A Cooper^1,6 , Praphan Phanuphak¹ and the HIV-NAT 010 Study Team

¹The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), the Thai Red Cross AIDS Research Center, Bangkok, Thailand

²The South East Asia Research Collaboration with Hawaii (SEARCH), Bangkok, Thailand

³Khon Kaen University, Khon Kaen, Thailand

⁴Chulalongkorn University, Bangkok, Thailand

⁵The International Antiviral Evaluation Center (IATEC), Amsterdam, the Netherlands

⁶The National Center for HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales, Sydney, Australia

author email corresponding author email

AIDS Research and Therapy 2008, 5:24doi:10.1186/1742-6405-5-24

Published:	28 October 2008

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.