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Published on: April 9, 2014
A feasibility study of immediate versus deferred antiretroviral therapy in children with HIV infection
Jintanat Ananworanich1, Pope Kosalaraksa, Umaporn Siangphoe
1HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Thai Red Cross AIDS Research Center, Bangkok, Thailand. jintanat.a@hivnat.org
Insights
A pilot study found that while many children were ineligible for immediate antiretroviral therapy (ART), adherence and retention were excellent. A larger trial to determine optimal ART timing in children is feasible.
Area of Science:
- Pediatric infectious diseases
- Clinical trial methodology
- HIV/AIDS treatment
Background:
- Antiretroviral therapy (ART) initiation timing in children with HIV is debated.
- Optimizing ART initiation can impact treatment outcomes and resource utilization.
Purpose of the Study:
- To assess the feasibility of a large-scale study comparing immediate versus deferred ART in children.
- To evaluate recruitment, adherence, and retention in a pilot randomized clinical trial.
Main Methods:
- An open-label pilot randomized trial involving 43 Thai children with CD4 counts between 15-24%.
- Children were randomized to immediate ART (Arm 1) or deferred ART until CD4 < 15% or CDC C (Arm 2).
- Primary endpoints included recruitment rate, adherence, and retention; secondary endpoints assessed clinical progression.
Main Results:
- Recruitment took 15 months; 37.7% of screened children were ineligible due to low CD4%.
- Adherence and retention were excellent in both arms, with 100% completion in Arm 1 and 90% in Arm 2.
- Deferred ART resulted in a 26% cost saving with similar clinical and virological outcomes compared to immediate ART.
Conclusions:
- Despite eligibility challenges, a larger study on ART timing in children is feasible.
- Excellent adherence and retention support the potential for a definitive trial.
- Deferred ART initiation may offer significant cost savings without compromising patient outcomes.
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.
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