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Session 130 Poster Abstracts
Treatment in Pregnant Women and Children: Treatment Interruptions
Wednesday, 1:30 - 3:30 pm
Poster Hall


948    
Virologic and Clinical Outcomes of a Progressively Increasing Structured Treatment Interruption Study in Chronically Infected Children
R Yogev*, B Borkowsky, P Muresan, T Fenton, E McFarland, L Frenkel, E Capparelli, B Heckman, J Moye, and S Jankelevich
1Chicago Children's Mem. Hosp., IL, USA; New York Univ. Med. Ctr., NY, USA; Harvard Sch. of Publ. Hlth., Boston, MA, USA; Univ. of Colorado Hlth. Sci. Ctr., Denver, USA; Children's Hosp. and Med. Ctr., Seattle, WA, USA; Univ. of California, San Diego, USA; Frontier Sci. and Technology Res. Fndn., Amherst, NY, USA; NICHD, NIH, DHHS, Bethesda, MD, USA; and NIAID, NIH, DHHS, Bethesda, MD, USA

Background:  In chronically HIV-infected patients who demonstrate good viral suppression on HAART, a brief increase in HIV viremia following interruption of therapy allows longer treatment cessations. We previously reported that progressively increasing structured treatment interruption in pediatric patients demonstrated that viremia resumed sooner than reported in adults, and suppression of the virus with re-introduction of HAART was achieved without difficulty. This report is a follow-up on 11 children with multiple cycling on and off HAART.

Methods:  We enrolled 11 pediatric patients, whose plasma viremia had been suppressed (<400 copies/mL) for >1 year and who had had <50 copies at baseline, in a nonrandomized structured treatment interruption protocol with progressively increasing periods off therapy. Starting with a 3-day structured treatment interruption during the first monthly cycle, subsequent structured treatment interruption periods increase by 2 days for each subsequent cycle. The dynamics of viral load, T-cell numbers, and HIV-specific CD4 and CD8 immune responses were monitored, as well as RT/Pol genotyping of detectable viruses. A control population, without structured treatment interruption, was also studied.

Results:  Plasma HIV levels increased above 50 copies/mL in all 11 patients by cycle 5 (11 days off HAART). Six patients had a breakthrough after only 7 days. In each patient subsequent structured treatment interruptions were followed by increased plasma viral load. In a few patients a lower plasma RNA was found in later structured treatment interruption cycles. As of October 2003, 3 patients had been off HAART for at least 21 days. In all patients resumption of HAART for 1 to 3 months was successful in suppressing viral load to <50 copies/mL. The 7 subjects who reached cycle 9 (19 days off HAART) had a median change from baseline of -1 (range -10, 5) in CD4%, +4 (range -6, 18) in CD8% and -165/mm3 (range -839 + 698) in total lymphocyte count.

Conclusions:  Progressive structured treatment interruption with maintenance of relative CD4 count and resumption of viral suppression can be accomplished in children well controlled on stable HAART. Preliminary data suggest that viral rebound may decrease after multiple cycles.

 

 

Keywords: pediatric; structured treatment interruption (STI); immunotherapy