Discontinuation of primary prophylaxis for Pneumocystis carinii pneumonia and toxoplasmic encephalitis in human immunodeficiency virus type I-infected patients: the changes in opportunistic prophylaxis study.
A multicenter open, randomized, controlled trial was conducted to determine whether primary prophylaxis for Pneumocystis carinii pneumonia and toxoplasmic encephalitis can be discontinued in patients infected with human immunodeficiency virus type 1 (HIV-1) whose CD4+ T cell counts have increased to >200 cells/mm3 (and who have remained at this level for at least 3 months) as a result of highly active antiretroviral therapy (HAART). Patients were randomized to either the discontinuation arm (i.e., those who discontinued prophylaxis; n=355) or to the continuation arm (n=353); the 2 arms of the study were similar in terms of demographic, clinical, and immunovirologic characteristics. During the median follow-ups of 6.4 months (discontinuation arm) and 6.1 months (continuation arm) and with a total of 419 patient-years, no patient developed P. carinii pneumonia or toxoplasmic encephalitis. The results of this study strongly indicate that primary prophylaxis for P. carinii pneumonia and toxoplasmic encephalitis can be safely discontinued in patients whose CD4+ T cell counts increase to >200 cells/mm3 during HAART.
Mussini
C
C
Dept. of Infectious Diseases, Policlinico, University of Modena and Reggio Emilio Hospital, 41100 Modena, Italy. crimuss@unimo.it.
Pezzotti
P
P
Govoni
A
A
Borghi
V
V
Antinori
A
A
d'Arminio Monforte
A
A
De Luca
A
A
Mongiardo
N
N
Cerri
M C
MC
Chiodo
F
F
Concia
E
E
Bonazzi
L
L
Moroni
M
M
Ortona
L
L
Esposito
R
R
Cossarizza
A
A
De Rienzo
B
B
D017088:AIDS-Related Opportunistic Infections / Q000517:prevention & control*; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D000890:Anti-Infective Agents / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D015497:HIV-1; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D010297:Paris; D010419:Pentamidine / Q000627:therapeutic use*; D011020:Pneumonia, Pneumocystis / Q000517:prevention & control*; D013997:Time Factors; D016781:Toxoplasmosis, Cerebral / Q000517:prevention & control*; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D000890:Anti-Infective Agents; D000981:Antiprotozoal Agents; D010419:Pentamidine; D015662:Trimethoprim, Sulfamethoxazole Drug Combination