AEGiS-08IAC: Dapsone-pyrimethamine (D/P) vs aerosolized pentamidine (AP) for primary prophylaxis of pneumocystosis (PCP) and neurotoxoplasmosis. The PRIO Group.

8th International AIDS Conference

Amsterdam, Netherlands — July 19-24, 1992

Dapsone-pyrimethamine (D/P) vs aerosolized pentamidine (AP) for primary prophylaxis of pneumocystosis (PCP) and neurotoxoplasmosis. The PRIO Group.

Int Conf AIDS 1992 Jul 19-24; 8:We48 (abstract no. WeB 1017)
Girard PM, Landman R, Gaudebout C, Jelasko P, Gaudebout C, Certain A, Olivares R, Coulaud JP; INSERM U13, Paris, France.

OBJECTIVES: To compare D/P vs AP for primary prophylaxis of PCP and to assess the value of D/P for primary prophylaxis of neurotoxoplasmosis.

METHODS: From July 89 to December 90, a multicenter, randomized, controlled trial recruited 362 symptomatic HIV patients (pts) with CD4 lymphocytes count below 200/mm3 and without history of PCP or neurotoxoplasmosis and/or contraindication to either regimen. Pts were randomized to receive AP, 300 mg monthly via a Respirgard II nebulizer, or dapsone (50mg/day) + pyrimethamine (50mg/wk) and folinic acid (25mg/wk). At randomization, pts were stratified according to their clinical status (AIDS/non AIDS) and to prior therapy with zidovudine. Analysis was done according to the intention-to-treat rule in 349 patients having received at least one dose of treatment.

RESULTS: The trial was discontinued in Dec. 91 (mean follow up of 476 +/- 137 d) on the basis of the interim analysis disclosing a highly significant protective effect of D/P against toxoplasmosis: 29 cases in AP group vs 15 in D/P group. (Log rank, p = 0.016); 7 of these 15 toxoplasmosis cases occurred after discontinuation of D/P. Toxoplasmosis occurred in sero-toxo positive pts only. Seven and 9 cases of proved or presumptive PCP were diagnosed in D/P and AP group, respectively (Log rank, p = 0.62). Interruption of prophylaxis for side effects was more frequent under DP (n = 40/173) than under AP (n = 3/176), p less than 10(-3). The most frequent of these side effects were cutaneous (n = 15) and/or hematological (n = 12).

CONCLUSIONS: (1) D/P and AP are equally effective for preventing first episode of PCP (2) D/P is an effective prophylaxis of first episode of toxoplasmosis (3) D/P is significantly less well tolerated than AP.

Keywords: AEGIS, Pentamidine, Toxoplasmosis, Cerebral, Pneumonia, Pneumocystis carinii, Dapsone, Pyrimethamine, Acquired Immunodeficiency Syndrome, HIV Infections, Zidovudine, Antifungal Agents, Antiprotozoal Agents, Nebulizers and Vaporizers, CD4-Positive T-Lymphocytes, HIV Seropositivity, HIV-1, Phosphatidylserines, HIV, Human, prevention & control, ICA8
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