Abstract | OBJECTIVE: PARTICIPANTS: Patients recovering from a first confirmed episode of AIDS-related P. carinii pneumonia who had no evidence of either another active AIDS-defining opportunistic infection or another pulmonary abnormality were considered eligible for the study but were included only if they had received no immunomodulators or antiretroviral agents other than zidovudine within 30 days of entry. One hundred sixty-two patients were randomized and started on the study drug. INTERVENTION: Patients were randomly assigned to receive aerosol pentamidine, 60 mg per dose, or placebo, delivered using a hand-held, patient-triggered, ultrasonic nebulizer. The induction phase of treatment consisted of 5 doses over 14 days, followed by a maintenance phase beginning on day 21 and consisting of one dose every 2 weeks. RESULTS: Thirty-two cases of P. carinii pneumonia were diagnosed before the termination of the trial; 27 cases occurred among 78 patients receiving placebo and 5 occurred among 84 patients receiving aerosol pentamidine. Estimates of the cumulative relapse rate of P. carinii pneumonia by 24 weeks were 50% and 9% for the placebo and pentamidine groups, respectively (P less than 0.001). Adverse reactions attributed to the study drug occurred in 15 of 78 patients receiving placebo and in 28 of 84 patients receiving pentamidine (P = 0.04). These were all mild or moderate in severity and did not preclude continued administration of the study drug. CONCLUSION:
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Authors | J S Montaner, L M Lawson, A Gervais, R H Hyland, C K Chan, J M Falutz, P M Renzi, D MacFadden, A R Rachlis, I W Fong |
Journal | Annals of internal medicine
(Ann Intern Med)
Vol. 114
Issue 11
Pg. 948-53
(Jun 01 1991)
ISSN: 0003-4819 [Print] United States |
PMID | 2024862
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aerosols
- Placebos
- Zidovudine
- Pentamidine
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Topics |
- Acquired Immunodeficiency Syndrome
(complications, drug therapy)
- Adult
- Aerosols
- Bronchial Spasm
(chemically induced)
- Cough
(chemically induced)
- Female
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Pentamidine
(administration & dosage, adverse effects)
- Placebos
- Pneumonia, Pneumocystis
(etiology, prevention & control)
- Recurrence
- Statistics as Topic
- Zidovudine
(therapeutic use)
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