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Discontinuation of Toxoplasmic Encephalitis Prophylaxis Is Safe in HIV-1 and T. gondii Co-Infected Patients after Immunological Recovery with HAART. Preliminary Results of the GESIDA 04/98-B Study J. M. MIRO*1, J. C. LOPEZ2, D. PODZAMCZER3, J. M. PEÑA4, C. ALBERDI2, X. CLARAMONTE1, E. MARTÍNEZ1, J. COSIN2, J. GONZALEZ4, P. DOMINGO5, J. L. CASADO6, E. RIBERA7, and the GESIDA 04/98B Study Group.
1Hosps. Clin., 3Bellvitge, 5Sant Pau, and 7Vall d’Hebrón (Barcelona), and 2Hosps. Gregorio Marañón, 3La Paz, and 6Ramón y Cajal (Madrid). Spain Background: Prophylaxis (PRO) to prevent toxoplasmic encephalitis (TE) is recommended in all HIV-1 infected patients with a positive T. gondii serology who have CD4+ cell counts under 100/uL or with previous TE episode. However the use of HAART leads to a sustained increase in CD4 cells and currently for some opportunistic infections such as PCP prophylaxis can be safely discontinuated.
Objective: To evaluate the safety of discontinuing TE PRO in HIV-1 and T. gondii co-infected patients with immunological recovery after HAART.
Methods: Prospective, randomised, open and multicentric study to withdrawn or not TE PRO. All patients had to meet the following criteria: 1) Positive T. gondii serology or TE episode; 2) Previous CD4+ cell counts <200/uL; 3) To be ongoing TE PRO and 4) Immunological and virological response to HAART: CD4+ > 200/uL and VL< 5.000 copies/mL for more than 3 months.
Results: 302 patients were included up to September 30, 1999: 155 withdraw PRO (group A), and 147 continue PRO (group B). Mean age was 37 years and 79% were male. HIV-1 risk factor was i.v. drug abuse in 50% of patients. 17 patients dropped out the study (6 in group 1 versus 11 in group 2). The median nadir CD4 cells were 99 (105 vs 94). 41% of patients were in group C of the 1993 CDC classification (43% vs 39%) and 20 had a TE episode and were on secondary prophylaxis (9 vs 11). At the moment of enrollment the median CD4 cells were 336 (343 vs 330), patients were on TE PRO for a median of 33 months (33 vs 32) and patients were on HAART for a median of 8 months (9 vs 8). All of these differences were non-significant. After a median of 10 months of follow-up there were no episodes of TE, “C event” or death in any group.
Conclusions: The preliminary results of this study indicate that primary or secondary TE PRO may be safely discontinued in HIV-1 infected patients with a sustained immunological response to HAART.
Key Words: discontinuation, prophylaxis, toxoplasmosis
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