[MoOrB1007] Discontinuation of toxoplasmic encephalitis (TE) maintenance therapy

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Discontinuation of toxoplasmic encephalitis (TE) maintenance therapy

[AUTHOR(S):] J.M. Miro, X. Claramonte, E. Martinez¹, J.C. Lopez, J.C. Alberdi, J. Cosin², D. Podzamczer, M. Santin³, J.M. Peña, J.R. Arribas⁴, P. Domingo⁵, J.L. Casado⁶, E. Ribera⁷, V. de Miguel⁸

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. MoOrB1007

BACKGROUND: The aim of this study was to evaluate the safety of discontinuing TE MT in HIV-1-infected patients after immunological reconstitution with HAART.

METHODS: Prospective, randomised, open & multicentric trial to evaluate withdrawal or not of TE MT. All patients had to meet the following criteria: 1) Previous TE episode; 2) To be on TE MT and 3) Immunological and virological response to HAART: CD4+ >200/mL & HIV-1 VL<5,000 copies/mL for more than 3 months. Enrolment period: July 1998 - June 2000.

RESULTS: 57 patients were included. Mean age was 36 years and 82% were males. HIV-1 risk factor was i.v. drug abuse in 46% of patients. Median (range) number of TE lesions during the acute episode was 2 (1-4). The median CD4 cell count was 30/mL. In 28 cases MT was withdrawn (group A) and in 29 MT was continued (group B). None of the patients dropped out of the trial. Patients were on TE MT for a median of 28 months (27 vs 30) and on HAART for a median of 25 months (24 vs 27). All but 2 patients received a protease inhibitor-based regimen. At the moment of enrolment, the median CD4 cell count was 390 (416 vs 364) and HIV-1 VL was <500 copies/mL in 86% of cases (86% vs 86%)(p=NS). After a median of 15 (16 vs 14) months of follow-up there were no episodes of TE (95% CI 0-8.69 vs 0-10.13 episodes per 100 person-years) or C events in any group. There was one non-HIV-related death in group A and one patient needed to resume TE MT due to a decrease of CD4 cell count <200 cells/uL in group B. After these results, 55 patients discontinued TE MT in October, 2000. All cases were followed-up until December 2001. None of the patients needed to resume TE MT. There was another non-HIV-related death. Overall, after 94 person-years of follow-up, there were no TE episodes in the 55 patients who discontinued TE MT (95%CI was 0-3.92 episodes per 100 person-years).

CONCLUSIONS: TE MT can be safely discontinued in HIV-1 infected patients with a sustained immunological response to HAART

Presenting author: Jose M. Miro

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1Hospital Clinic - Idibaps, Infectious Diseases Service, Hospital Clinic - Idibaps, Villarroel, 170, 08036-Barcelona, Spain.

2Hospital Gregorio Marañon, Madrid, Spain.

3Hospital de Bellvitge, Hospitalet (Barcelona), Spain.

4Hospital La Paz, Madrid, Spain.

5Hospital San Pau, Barcelona, Spain.

6Hospital Ramon y Cajal, Madrid, Spain.

7Hospital Vall d'Hebron, Barcelona, Spain.

8AEC-GESIDA, Madrid, Spain.

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MoOrB1007