Antiretroviral therapy (ART) during the earliest stage of acute HIV infection (Fiebig I) might minimize establishment of a latent HIV reservoir and thereby facilitate viremic control after analytical treatment interruption (ATI). We show that 8 participants, who initiated treatment during Fiebig I and were treated for a median of 2.8 years, all experienced rapid viral load rebound following ATI, indicating that additional strategies are required to control or eradicate HIV.

Early ART resulted in very low levels of markers of HIV persistence and undetectable HIV-specific immune responses in the majority of HIV-infected children who started ART before 6 months of age.

has received a speaker fee from Gilead Sciences. Nicolas Chomont has served on the scientific advisory board of Theravectys. Jintanat Ananworanich has participated in advisory meetings for ViiV Healthcare, Merck, AbbVie, Gilead, and Roche. The remaining authors report no relevant conflicts of interest. DATA SHARING STATEMENT The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) and the U.S. Department of the Army are committed to safeguarding the privacy of research participants. De-identified participant-level data and accompanying research resources are available upon request. Distribution of data will require compliance with all applicable regulatory and ethical processes, including establishment and approval of an appropriate data-sharing agreement. The research protocol, informed consent documents, and instructions for submitting data requests can be found at https://www.hivresearch.org/RV397_Protocol.

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Acute HIV infection is commonly associated with mild neurologic findings that largely remit while on treatment, and may be mediated by direct viral factors. Severe neurologic manifestations are infrequent in treated acute HIV.

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We are indebted to the RV397 participants and study team (Supplemental Acknowledgments). The authors thank Diane Bolton, Paul Edlefsen, and Daniel Reeves. This work was supported by a cooperative agreement between the Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., and the US Department of the Army (W81XWH-18-2-0174). The views expressed are those of the authors and should not be construed to represent the positions of the US Army, the Department of Defense, or the Department of Health and Human Services.

ObjectiveTo evaluate the feasibility of a large immediate versus deferred antiretroviral therapy (ART) study in children.MethodsWe 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.ResultsRecruitment 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.ConclusionAlmost 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.