PMID- 15622314 OWN - NLM STAT- MEDLINE DCOM- 20050203 LR - 20191210 IS - 0269-9370 (Print) IS - 0269-9370 (Linking) VI - 18 IP - 18 DP - 2004 Dec 3 TI - CD4+ cell-count-guided treatment interruptions in chronic HIV-infected patients with good response to highly active antiretroviral therapy. PG - 2381-9 AB - OBJECTIVE: To evaluate the safety of treatment interruption guided by CD4+ cell count in HIV-infected patients followed up prospectively. METHODS: Patients on highly active antiretroviral therapy with CD4+ cell counts > 500 x 10(6) cells/l discontinued therapy with instructions to start therapy again before their CD4+ count dropped below 200 x 10(6) cells/l. Any patients who resumed therapy would be eligible to interrupt treatment again once their CD4+ cell count increased above 500 x 10(6) cells/l. RESULTS: Data on 71 HIV infected patients is reported. Their median nadir CD4+ cell count before antiretroviral treatment was 352 x 10(6) cells/l [interquartile range (IQR), 294-445 x 10(6) cells/l]. The median CD4+ cell count at the time of first interruption was 790 x 10(6) cells/l (IQR, 657-1041 x 10(6) cells/l). The median follow-up after starting the first treatment interruption was 28.3 months (IQR, 21.4-37.0 months). During the follow-up 49 patients restarted therapy and 22 patients remain off therapy; 24 patients have interrupted therapy twice, nine patients have interrupted therapy three times and six patients four times. No AIDS-defining illnesses occurred during the follow-up. The median duration of the first interruption was 15 months (IQR, 6-26 months). The overall reduction of time on therapy was 71.1%. The duration of the first interruption and the reduction of time on therapy were related to nadir CD4+ cell count. The patients who resumed HAART rapidly regained CD4+ cells and achieved viral suppression. CONCLUSION: If carefully monitored, treatment interruptions guided by CD4+ cell count in patients with an initially high CD4+ cell counts are clinically safe, decrease exposure to the drugs and do not reduce the efficacy of therapy when this is re-started. FAU - Boschi, Andrea AU - Boschi A AD - Division of Infectious Diseases AUSL Rimini, Via Settembrini 2, 49300 Rimini (RN), Italy. boschia@libero.it FAU - Tinelli, Carmine AU - Tinelli C FAU - Ortolani, Patrizia AU - Ortolani P FAU - Moscatelli, Gianluigi AU - Moscatelli G FAU - Morigi, Giorgio AU - Morigi G FAU - Arlotti, Massimo AU - Arlotti M LA - eng PT - Evaluation Study PT - Journal Article PL - England TA - AIDS JT - AIDS (London, England) JID - 8710219 SB - IM MH - Adult MH - *Antiretroviral Therapy, Highly Active MH - CD4 Lymphocyte Count MH - Chronic Disease MH - Cohort Studies MH - Female MH - HIV Infections/*drug therapy/immunology MH - Humans MH - Male MH - Prospective Studies MH - Viral Load MH - *Withholding Treatment EDAT- 2004/12/29 09:00 MHDA- 2005/02/04 09:00 CRDT- 2004/12/29 09:00 PHST- 2004/12/29 09:00 [pubmed] PHST- 2005/02/04 09:00 [medline] PHST- 2004/12/29 09:00 [entrez] AID - 00002030-200412030-00005 [pii] PST - ppublish SO - AIDS. 2004 Dec 3;18(18):2381-9.